HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 29DEC23:12:47:4829DEC23:12:47:48 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS _1257722SASDATA 6.06 29DEC23:12:47:4829DEC23:12:47:48 Supplemental Qualifiers for AE HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001000000000000000000000 STUDYID Study Identifier RDOMAIN Related Domain Abbreviation USUBJID Unique Subject Identifier IDVAR Identifying Variable  IDVARVALIdentifying Variable Value %QNAM Qualifier Variable Name 1$QLABEL Qualifier Variable Label 9SQVAL Data Value ] QORIG Origin  QEVAL Evaluator HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001AEC4591001 1005 10051317AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1005 10051317AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051317AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051317AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051317AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051317AESEQ1 LSTCGDTCDate/Time of Last change 2020-11-12T21:04:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051317AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051317AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051328AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051328AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051328AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051328AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051328AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051328AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-25T20:35:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051339AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1005 10051339AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051339AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051339AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1005 10051339AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051339AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051339AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-18T18:05:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051339AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051339AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051339AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051339AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051339AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051339AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T20:56:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051417AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051417AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051417AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051417AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051417AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051417AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-09T23:28:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051420AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1005 10051420AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051420AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051420AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1005 10051420AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051420AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051420AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-11T13:19:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051420AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1005 10051420AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051420AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051420AESEQ2 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1005 10051420AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051420AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051420AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-11T13:19:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051424AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051424AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051424AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051424AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-27T04:17:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1005 10051424AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051424AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051424AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051424AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ2 LSTCGDTCDate/Time of Last change 2021-01-27T04:17:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051424AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051424AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051424AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051424AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ3 LSTCGDTCDate/Time of Last change 2021-01-27T14:02:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051424AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051424AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051424AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051424AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ4 LSTCGDTCDate/Time of Last change 2021-01-27T04:17:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1005 10051424AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051424AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051424AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051424AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051424AESEQ5 LSTCGDTCDate/Time of Last change 2021-01-27T04:17:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051427AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051427AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051427AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051427AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051427AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051427AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T13:00:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051427AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051427AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051427AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051427AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051427AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051427AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T13:01:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051436AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051437AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051437AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051437AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051437AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051437AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051437AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-28T17:28:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051437AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051437AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051437AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051437AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051437AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051437AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-28T17:28:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051438AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051438AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051441AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051445AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051449AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051449AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051449AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1005 10051449AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1005 10051449AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051449AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051449AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-27T11:37:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051450AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1005 10051450AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1005 10051450AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1005 10051450AESEQ1 AERELTXTEvent Due to Other Specify outdoor activities CRF C4591001AEC4591001 1005 10051450AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1005 10051450AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051450AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-06T13:01:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051451AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1005 10051451AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061183AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061183AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061183AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061183AESEQ1 AERELTXTEvent Due to Other Specify Sports Injury CRF C4591001AEC4591001 1006 10061183AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061183AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061183AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T19:57:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061183AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061183AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061183AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061183AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061183AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061183AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T19:08:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061191AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061196AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061196AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061196AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061196AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061196AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061196AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:01:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061203AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-05T02:15:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061203AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-06T00:30:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061203AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ3 LSTCGDTCDate/Time of Last change 2021-02-05T02:15:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061203AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ4 LSTCGDTCDate/Time of Last change 2021-02-06T00:30:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061203AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ5 LSTCGDTCDate/Time of Last change 2021-02-06T00:30:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061203AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ6 LSTCGDTCDate/Time of Last change 2021-02-11T23:57:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061203AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061203AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061203AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061203AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061203AESEQ7 LSTCGDTCDate/Time of Last change 2021-02-05T02:15:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061207AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061209AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061209AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061209AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061209AESEQ1 AERELTXTEvent Due to Other Specify blood draw CRF C4591001AEC4591001 1006 10061209AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061209AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061209AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-12T20:09:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061220AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061221AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061221AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061223AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061223AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061223AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061223AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061223AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061223AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T21:14:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061224AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061226AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061226AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061226AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061226AESEQ1 AERELTXTEvent Due to Other Specify established diagnosis CRF C4591001AEC4591001 1006 10061226AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061226AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061226AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-02T23:29:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061228AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061228AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061228AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061228AESEQ1 AERELTXTEvent Due to Other Specify Established diagnosis CRF C4591001AEC4591001 1006 10061228AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061228AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061228AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-14T22:46:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061228AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061228AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061228AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061231AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061245AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061245AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061245AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061245AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061245AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061245AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-26T23:14:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061245AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061245AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061245AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061245AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061245AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061245AESEQ2 LSTCGDTCDate/Time of Last change 2020-12-30T15:20:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061252AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061252AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061253AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061253AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061253AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061253AESEQ1 AERELTXTEvent Due to Other Specify basketball injury CRF C4591001AEC4591001 1006 10061253AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061253AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061253AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T21:14:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061258AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061258AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061258AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061258AESEQ1 AERELTXTEvent Due to Other Specify VIRAL CRF C4591001AEC4591001 1006 10061258AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061258AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061258AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T17:41:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061259AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061264AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061264AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061264AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061266AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061266AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061266AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061266AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061266AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061266AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-17T18:54:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061269AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061269AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061269AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061270AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061272AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061272AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061272AESEQ1 AERELTXTEvent Due to Other Specify Stress CRF C4591001AEC4591001 1006 10061272AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061272AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-25T17:10:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061272AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061272AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061272AESEQ2 AERELTXTEvent Due to Other Specify Fall on ice CRF C4591001AEC4591001 1006 10061272AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061272AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-30T20:23:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061272AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061272AESEQ3 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061272AESEQ3 AERELTXTEvent Due to Other Specify Stress CRF C4591001AEC4591001 1006 10061272AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061272AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ3 LSTCGDTCDate/Time of Last change 2021-05-18T14:26:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061272AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061272AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061272AESEQ4 AERELTXTEvent Due to Other Specify Icy conditions CRF C4591001AEC4591001 1006 10061272AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061272AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-08T16:02:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061272AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061272AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061272AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061272AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061272AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-21T20:20:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061274AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061274AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061274AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061274AESEQ1 AERELTXTEvent Due to Other Specify HORMONAL CHANGES CRF C4591001AEC4591001 1006 10061274AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061274AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061274AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-03T07:25:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061279AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061279AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061279AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061279AESEQ1 AERELTXTEvent Due to Other Specify Outgrew anxiety med dose CRF C4591001AEC4591001 1006 10061279AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061279AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061279AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-04T18:46:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061279AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061279AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061279AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061279AESEQ2 AERELTXTEvent Due to Other Specify Acute Physical Trauma CRF C4591001AEC4591001 1006 10061279AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061279AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061279AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-04T18:48:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061279AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061279AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061279AESEQ3 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061279AESEQ3 AERELTXTEvent Due to Other Specify viral infection CRF C4591001AEC4591001 1006 10061279AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061279AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061279AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-12T18:46:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061282AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061284AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061285AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061285AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061285AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061285AESEQ1 AERELTXTEvent Due to Other Specify mechanical irritation, concentrated urine CRF C4591001AEC4591001 1006 10061285AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061285AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061285AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-04T20:50:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061285AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061285AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061285AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061285AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061285AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061285AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-23T00:00:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061286AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061286AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061286AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061286AESEQ1 AERELTXTEvent Due to Other Specify SKIING INJURY CRF C4591001AEC4591001 1006 10061286AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061286AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061286AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-09T16:43:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061286AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061286AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061286AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061286AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061286AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061286AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-10T02:18:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061286AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061290AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061290AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061290AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061290AESEQ1 AERELTXTEvent Due to Other Specify Fall (cheer) CRF C4591001AEC4591001 1006 10061290AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061290AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061290AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-20T22:11:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061290AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061290AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061292AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1006 10061292AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061292AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1006 10061292AESEQ1 AERELTXTEvent Due to Other Specify Wax overproduction and packing CRF C4591001AEC4591001 1006 10061292AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061292AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061292AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-15T19:55:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061292AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1006 10061292AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1006 10061292AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1006 10061292AESEQ2 AERELTXTEvent Due to Other Specify Surgery CRF C4591001AEC4591001 1006 10061292AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1006 10061292AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1006 10061292AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-06T22:21:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071409AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071409AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071409AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071409AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-01T23:34:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071409AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071409AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071409AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071409AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-01T23:34:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071409AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071409AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071409AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071409AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-01T23:34:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071409AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071409AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071409AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071409AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071409AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-01T23:34:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071414AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071414AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071414AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071414AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071414AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071414AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-14T21:59:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071414AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071414AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071414AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071414AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071414AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071414AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-14T21:59:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071476AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071476AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071476AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071476AESEQ1 AERELTXTEvent Due to Other Specify vasovagal event from blood collection CRF C4591001AEC4591001 1007 10071476AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071476AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071476AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-21T22:39:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071476AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071476AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071476AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071476AESEQ2 AERELTXTEvent Due to Other Specify Anxiety CRF C4591001AEC4591001 1007 10071476AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071476AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071476AESEQ2 LSTCGDTCDate/Time of Last change 2020-12-23T03:04:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071480AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-21T20:09:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071480AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ2 AERELTXTEvent Due to Other Specify Varicella-zoster virus CRF C4591001AEC4591001 1007 10071480AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T19:31:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071480AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-28T11:28:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071480AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-21T20:08:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071480AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ5 AERELTXTEvent Due to Other Specify Shingles related pain CRF C4591001AEC4591001 1007 10071480AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-23T10:29:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071480AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ6 AERELTXTEvent Due to Other Specify shingles CRF C4591001AEC4591001 1007 10071480AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-07T19:45:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071480AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071480AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071480AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071480AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071480AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-21T20:09:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071483AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071483AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071483AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071483AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071483AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071483AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-21T10:56:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071484AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071484AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071484AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071484AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-13T19:56:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071484AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071484AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071484AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071484AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-13T19:54:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071484AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071484AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071484AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071484AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-13T19:52:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071484AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071484AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071484AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071484AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071484AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-13T19:53:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071497AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071497AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071497AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071497AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071497AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071497AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-31T15:05:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071499AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071499AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071499AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071499AESEQ1 AERELTXTEvent Due to Other Specify Trauma CRF C4591001AEC4591001 1007 10071499AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071499AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071499AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-26T17:15:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071499AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071500AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071500AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071500AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071500AESEQ1 AERELTXTEvent Due to Other Specify stress CRF C4591001AEC4591001 1007 10071500AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071500AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071500AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-29T15:39:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071505AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071505AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T13:25:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071505AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T13:24:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071505AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-29T15:53:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071505AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-29T15:53:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071505AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-29T15:54:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071505AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-23T21:38:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071505AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-29T15:53:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ8 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071505AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071505AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071505AESEQ8 AERELTXTEvent Due to Other Specify Possible VP shunt malfunction CRF C4591001AEC4591001 1007 10071505AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071505AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071505AESEQ8 LSTCGDTCDate/Time of Last change 2021-08-04T15:29:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071509AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071509AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071509AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071509AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071509AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071509AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-10T11:04:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071511AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071511AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071511AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071511AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071511AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071511AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T17:03:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071511AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071511AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071511AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071511AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071511AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071511AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T17:04:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071516AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071516AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071516AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071516AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071516AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071516AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T17:09:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071516AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071516AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071516AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071516AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071516AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071516AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T17:08:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071519AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071519AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071519AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071519AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071519AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071519AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-21T23:28:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071524AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071524AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071524AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071524AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071524AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071524AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-03T20:29:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071526AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071531AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071531AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071531AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071531AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071531AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071531AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-23T12:12:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071531AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071531AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071531AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071531AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071531AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071531AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-20T14:45:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071531AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071531AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071531AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071531AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071531AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071531AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-20T14:46:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071533AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071533AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071533AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071533AESEQ1 AERELTXTEvent Due to Other Specify Injury while exercising; no fall CRF C4591001AEC4591001 1007 10071533AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071533AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071533AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-19T02:33:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071533AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071547AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071547AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071547AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071547AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071547AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071547AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-10T16:58:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071547AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071547AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071547AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071547AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071547AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071547AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T16:58:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071547AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071547AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071559AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-22T13:47:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071559AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T11:25:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071559AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-07T20:55:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071559AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-07T20:54:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071559AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ5 AERELTXTEvent Due to Other Specify unknown etiology but headache is more than 7 days post COVID vaccine CRF C4591001AEC4591001 1007 10071559AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-10T11:26:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071559AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-22T13:47:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071559AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-22T13:44:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ8 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071559AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ8 LSTCGDTCDate/Time of Last change 2021-06-22T13:47:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ9 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071559AESEQ9 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071559AESEQ9 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071559AESEQ9 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071559AESEQ9 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071559AESEQ9 LSTCGDTCDate/Time of Last change 2021-06-22T13:47:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071561AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071562AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071562AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071562AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071562AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-24T15:48:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071562AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071562AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071562AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071562AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-14T18:40:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071562AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071562AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071562AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071562AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ3 LSTCGDTCDate/Time of Last change 2021-05-24T14:47:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071562AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071562AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071562AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071562AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-14T18:40:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071562AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071562AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071562AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071562AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ5 LSTCGDTCDate/Time of Last change 2021-05-25T23:23:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071562AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071562AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071562AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071562AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071562AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-14T18:41:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071563AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071563AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071563AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071563AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071563AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071563AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-18T16:28:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071568AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071568AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071568AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071568AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071568AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071568AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-06T02:26:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071568AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071568AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071568AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071568AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071568AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071568AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-02T14:39:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071569AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071575AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071575AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071575AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071575AESEQ1 AERELTXTEvent Due to Other Specify soccer injury CRF C4591001AEC4591001 1007 10071575AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071575AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071575AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-13T19:33:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071576AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071581AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071581AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071581AESEQ1 AERELTXTEvent Due to Other Specify Infection CRF C4591001AEC4591001 1007 10071581AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071581AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-30T18:43:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071581AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071581AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071581AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071581AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-17T14:18:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071581AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071581AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071581AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071581AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-17T14:17:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071581AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071581AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071581AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071581AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071581AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-17T15:15:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071583AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071583AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071583AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071583AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071583AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071583AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-14T16:47:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071583AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071583AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071583AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071583AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071583AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071583AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-14T16:47:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071584AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071584AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071584AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071584AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071584AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071584AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-04T20:54:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071585AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071585AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071585AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071585AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071585AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071585AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-01T15:23:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071585AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071586AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071586AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071586AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071586AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071586AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071586AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-22T17:05:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071588AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071593AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071593AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071593AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071593AESEQ1 AERELTXTEvent Due to Other Specify injury CRF C4591001AEC4591001 1007 10071593AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071593AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071593AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-15T02:09:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071595AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071595AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071595AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071595AESEQ1 AERELTXTEvent Due to Other Specify Phlebotomy CRF C4591001AEC4591001 1007 10071595AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071595AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071595AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-30T21:09:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071596AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071596AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071596AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071596AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-21T11:17:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071596AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071596AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071596AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071596AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-21T11:17:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071596AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071596AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071596AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071596AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-21T11:18:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071596AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071596AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071596AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071596AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071596AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-21T11:18:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071600AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071600AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071600AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071600AESEQ1 AERELTXTEvent Due to Other Specify depression CRF C4591001AEC4591001 1007 10071600AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071600AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071600AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-10T03:56:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071600AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071600AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071600AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071600AESEQ2 AERELTXTEvent Due to Other Specify Depression CRF C4591001AEC4591001 1007 10071600AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071600AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071600AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-02T08:58:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071613AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071613AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071613AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071613AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071613AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071613AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-29T14:26:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071614AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071614AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071614AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071614AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-13T21:38:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071614AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071614AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071614AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071614AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-13T21:38:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071614AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071614AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071614AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071614AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-13T21:38:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071614AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071614AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071614AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071614AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-13T21:37:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071614AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071614AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071614AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071614AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071614AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-13T21:37:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071615AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071615AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071615AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071615AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071615AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071615AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-10T21:43:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071617AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071617AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071617AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071617AESEQ1 AERELTXTEvent Due to Other Specify psychosocial stress CRF C4591001AEC4591001 1007 10071617AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071617AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071617AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-13T17:32:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071617AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071617AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071617AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071617AESEQ2 AERELTXTEvent Due to Other Specify psychosocial stress CRF C4591001AEC4591001 1007 10071617AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071617AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071617AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-13T17:33:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071618AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071618AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071618AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071618AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071618AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071618AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-29T14:26:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-15T02:05:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ2 AERELTXTEvent Due to Other Specify no organic cause; multiple life stressors CRF C4591001AEC4591001 1007 10071620AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-17T11:16:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ3 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071620AESEQ3 AERELTXTEvent Due to Other Specify pain CRF C4591001AEC4591001 1007 10071620AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ3 LSTCGDTCDate/Time of Last change 2021-04-06T11:12:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ4 AERELTXTEvent Due to Other Specify no organic cause identified CRF C4591001AEC4591001 1007 10071620AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-14T14:01:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ5 AERELTXTEvent Due to Other Specify no organic cause identified CRF C4591001AEC4591001 1007 10071620AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-14T15:08:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ6 AERELTXTEvent Due to Other Specify functional; multiple life stressors CRF C4591001AEC4591001 1007 10071620AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-08T19:26:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ7 AERELTXTEvent Due to Other Specify suspected reaction to tape CRF C4591001AEC4591001 1007 10071620AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-08T19:34:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ8 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ8 LSTCGDTCDate/Time of Last change 2021-06-08T19:33:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ9 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071620AESEQ9 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071620AESEQ9 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071620AESEQ9 AERELTXTEvent Due to Other Specify Presumed staph infection CRF C4591001AEC4591001 1007 10071620AESEQ9 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071620AESEQ9 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ9 LSTCGDTCDate/Time of Last change 2021-02-09T17:31:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071620AESEQ194000000005DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071622AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071623AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071623AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071623AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071623AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-22T21:47:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071623AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071623AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071623AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071623AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-22T21:47:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071623AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071623AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071623AESEQ3 AERELTXTEvent Due to Other Specify potential lacrosse injury CRF C4591001AEC4591001 1007 10071623AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071623AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ3 LSTCGDTCDate/Time of Last change 2021-08-18T17:01:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071623AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071623AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071623AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071623AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ4 LSTCGDTCDate/Time of Last change 2021-02-27T15:46:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071623AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071624AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071624AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071624AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071624AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071624AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071624AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T14:53:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071625AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071625AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071625AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071625AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071625AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071625AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T15:15:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071625AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071625AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071625AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071625AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071625AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071625AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T15:15:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071628AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071629AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T18:23:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T18:24:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-14T16:47:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-08T18:24:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071632AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-14T16:47:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-08T18:23:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ7 LSTCGDTCDate/Time of Last change 2021-02-24T22:37:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ8 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ8 LSTCGDTCDate/Time of Last change 2021-01-05T22:27:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ9 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ9 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ9 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ9 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ9 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ9 LSTCGDTCDate/Time of Last change 2021-01-27T11:40:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ10 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071632AESEQ10 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071632AESEQ10 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071632AESEQ10 AERELTXTEvent Due to Other Specify venipuncture CRF C4591001AEC4591001 1007 10071632AESEQ10 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071632AESEQ10 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ10 LSTCGDTCDate/Time of Last change 2021-01-27T11:39:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071632AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071634AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071634AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071634AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071634AESEQ1 AERELTXTEvent Due to Other Specify Most likely due to anxiety/fear of receiving an injection CRF C4591001AEC4591001 1007 10071634AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071634AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071634AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-10T13:14:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071634AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071634AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071634AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071634AESEQ2 AERELTXTEvent Due to Other Specify viral infection CRF C4591001AEC4591001 1007 10071634AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071634AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071634AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-27T15:50:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071640AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071640AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071640AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071640AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-29T14:40:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071640AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071640AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071640AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071640AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-29T14:40:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071640AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071640AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071640AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071640AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-22T21:47:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071640AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071640AESEQ4 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1007 10071640AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071640AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071640AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-29T14:40:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071642AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071642AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071642AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071642AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T14:29:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071642AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071642AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071642AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071642AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-07T14:29:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071642AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071642AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071642AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071642AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-07T14:30:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071642AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071642AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071642AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071642AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-07T14:29:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071642AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071642AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071642AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071642AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-07T14:28:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071642AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071648AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071648AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071648AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071648AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071648AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071648AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-01T15:45:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-21T15:34:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ2 AERELTXTEvent Due to Other Specify Anxiety CRF C4591001AEC4591001 1007 10071650AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-21T15:33:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-21T15:34:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-21T15:36:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-21T14:24:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-21T15:36:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071650AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071650AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071650AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071650AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071650AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-21T15:35:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071651AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071651AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071651AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071651AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071651AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071651AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-25T17:23:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071651AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071651AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071651AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071651AESEQ2 AERELTXTEvent Due to Other Specify Local adenopathy. Do not think related to study agent CRF C4591001AEC4591001 1007 10071651AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071651AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071651AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-14T13:17:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071651AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071652AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071652AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071652AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071652AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071652AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071652AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T13:16:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071658AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071658AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071658AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071658AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-14T15:20:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071658AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071658AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071658AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071658AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-14T15:21:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071658AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071658AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071658AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071658AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-14T15:19:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071658AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071658AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071658AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071658AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-21T17:19:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071658AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071658AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071658AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071658AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-14T15:19:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1007 10071658AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071658AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071658AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071658AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-14T13:51:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071658AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071660AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071660AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071660AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071660AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-20T14:49:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071660AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071660AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071660AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071660AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-20T14:53:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071660AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071660AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071660AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071660AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-20T14:48:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071660AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071660AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071660AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071660AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-20T14:50:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1007 10071660AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1007 10071660AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1007 10071660AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1007 10071660AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1007 10071660AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-20T14:52:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081761AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081761AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081761AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081761AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081761AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081761AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-27T23:11:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081763AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081767AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081767AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081768AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081771AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081773AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081781AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081781AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081781AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081781AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081781AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081781AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-07T15:53:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081781AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081781AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081781AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081781AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081781AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081781AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-07T15:54:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081781AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081788AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081788AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081788AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081788AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081788AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081788AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-04T00:10:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081788AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081801AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081801AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081801AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081801AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081801AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081801AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T21:29:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081803AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081803AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081808AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081808AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081808AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081808AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081808AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081808AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T21:29:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081808AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081808AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081808AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081808AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081808AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081808AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T21:29:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081810AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081810AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081810AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081812AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1008 10081812AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081812AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081812AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081812AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081812AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-04T16:56:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081817AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081817AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081817AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081817AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081817AESEQ194000000005DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081822AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081837AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081837AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081837AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081837AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T22:45:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1008 10081837AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081837AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081837AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081837AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T22:45:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1008 10081837AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081837AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081837AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081837AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-09T22:45:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081837AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081843AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081844AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1008 10081844AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081844AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081844AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081844AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081844AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-10T02:01:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081844AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081844AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081844AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081844AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081844AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081844AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T02:02:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081844AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081844AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081844AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081844AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081844AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081844AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-10T02:02:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081845AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081848AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081848AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081849AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081849AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081849AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081851AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081852AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081853AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081856AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081856AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081859AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081863AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081863AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081863AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081863AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081863AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081863AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T21:30:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081863AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081863AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081863AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081863AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081863AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081863AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T21:30:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081867AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081867AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081871AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081872AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081877AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081877AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081877AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081877AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081877AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081877AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T00:02:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081877AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081877AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081877AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081877AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081877AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081877AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T00:03:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081877AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081877AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081883AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081884AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081885AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081887AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081887AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081887AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081887AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081887AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081887AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-04T00:11:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081887AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081887AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081887AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081887AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081887AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081887AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-03T17:25:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081887AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081887AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081887AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081887AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081887AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081887AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-04T02:24:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081889AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081892AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081892AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081892AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081892AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081892AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081892AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-04T00:11:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081900AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081900AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081900AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081901AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081902AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081907AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081913AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081913AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081913AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081913AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081913AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081913AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T00:03:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081915AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081925AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081928AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1008 10081928AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081928AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081928AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081928AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081928AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-29T21:14:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081928AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081928AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081928AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081928AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081931AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1008 10081931AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081931AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081931AESEQ1 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1008 10081931AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081931AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081931AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-19T21:23:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081931AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081931AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081932AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081932AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081933AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1008 10081933AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1008 10081933AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1008 10081933AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1008 10081933AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081933AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T21:31:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1008 10081938AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091205AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091220AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091220AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091220AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091220AESEQ1 AERELTXTEvent Due to Other Specify PHYSIOLOGIC due to wisdom teeth removal CRF C4591001AEC4591001 1009 10091220AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091220AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091220AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-24T19:21:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091221AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091221AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091221AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1009 10091221AESEQ1 AERELTXTEvent Due to Other Specify dance injury CRF C4591001AEC4591001 1009 10091221AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091221AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091221AESEQ1 LSTCGDTCDate/Time of Last change 2020-11-25T18:24:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091229AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091229AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091229AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091229AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091229AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091229AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-12T14:30:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091229AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091229AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091231AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091231AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091231AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091231AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091231AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091231AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-15T20:40:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091237AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091237AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091267AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091267AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091267AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091267AESEQ1 AERELTXTEvent Due to Other Specify RHINORHEA FROM URI-VIRAL CRF C4591001AEC4591001 1009 10091267AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091267AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091267AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-22T04:19:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091283AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091284AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091294AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091294AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091294AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091294AESEQ1 AERELTXTEvent Due to Other Specify lifting heavy object CRF C4591001AEC4591001 1009 10091294AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091294AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091294AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-28T22:18:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091294AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091294AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091294AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091294AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091294AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091294AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-16T16:40:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091298AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091298AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091298AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091301AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091301AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091301AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091301AESEQ1 AERELTXTEvent Due to Other Specify insect bite CRF C4591001AEC4591001 1009 10091301AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091301AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091301AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-10T21:03:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091301AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091305AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091305AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091305AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091305AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091305AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091305AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T16:54:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091308AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091308AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091308AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091311AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091319AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091319AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091319AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091319AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1009 10091319AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091319AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091319AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-27T21:45:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091323AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091323AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091323AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091323AESEQ1 AERELTXTEvent Due to Other Specify prolonged fasting CRF C4591001AEC4591001 1009 10091323AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091323AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091323AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-13T05:29:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091323AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091323AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091323AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091323AESEQ2 AERELTXTEvent Due to Other Specify prolonged fasting CRF C4591001AEC4591001 1009 10091323AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091323AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091323AESEQ2 LSTCGDTCDate/Time of Last change 2021-01-13T05:29:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091326AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091326AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091326AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091326AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091326AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091326AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-01T02:22:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091326AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091326AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091326AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091326AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091326AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091326AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-01T14:59:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091334AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091334AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091334AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091334AESEQ1 AERELTXTEvent Due to Other Specify cooking fumes from hot peppers CRF C4591001AEC4591001 1009 10091334AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091334AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091334AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-18T20:41:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091338AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091338AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091338AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091338AESEQ1 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1009 10091338AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091338AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091338AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-01T17:27:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091338AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091338AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091338AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091338AESEQ2 AERELTXTEvent Due to Other Specify Surgery CRF C4591001AEC4591001 1009 10091338AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091338AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091338AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-01T15:56:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091340AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091340AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091340AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091341AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091341AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091341AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091341AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091341AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091341AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-08T20:03:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091342AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091342AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091342AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091342AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1009 10091342AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091342AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091342AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-21T09:53:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091343AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091357AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091357AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091357AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091357AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091357AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091357AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-16T16:40:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091357AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091357AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091357AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091357AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091357AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091357AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-16T16:40:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091357AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091357AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091357AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091357AESEQ3 AERELTXTEvent Due to Other Specify congenital CRF C4591001AEC4591001 1009 10091357AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091357AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091357AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-18T23:14:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091361AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091361AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091361AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091361AESEQ1 AERELTXTEvent Due to Other Specify thumb sprain from volleyball CRF C4591001AEC4591001 1009 10091361AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091361AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091361AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-03T17:08:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091362AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091362AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091362AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091363AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091363AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091363AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091363AESEQ1 AERELTXTEvent Due to Other Specify Secondary to veinipuncture CRF C4591001AEC4591001 1009 10091363AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091363AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091363AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-12T23:06:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091365AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091365AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091365AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091365AESEQ1 AERELTXTEvent Due to Other Specify accidental injury CRF C4591001AEC4591001 1009 10091365AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091365AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091365AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-29T15:53:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091366AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091366AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091366AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091366AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091366AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091366AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T18:40:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091370AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091370AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091370AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091370AESEQ1 AERELTXTEvent Due to Other Specify braces tightening CRF C4591001AEC4591001 1009 10091370AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091370AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091370AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-10T22:00:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091375AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091379AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091379AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091379AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091379AESEQ1 AERELTXTEvent Due to Other Specify FALL INJURY CRF C4591001AEC4591001 1009 10091379AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091379AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091379AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T21:02:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091379AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091379AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091379AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091379AESEQ2 AERELTXTEvent Due to Other Specify TRIP OVER SCOOTER CRF C4591001AEC4591001 1009 10091379AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091379AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091379AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-22T21:44:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091379AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091379AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091379AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091379AESEQ3 AERELTXTEvent Due to Other Specify physiologic CRF C4591001AEC4591001 1009 10091379AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091379AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091379AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-15T18:40:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091380AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091380AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091380AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091380AESEQ1 AERELTXTEvent Due to Other Specify Snowboarding Accident CRF C4591001AEC4591001 1009 10091380AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091380AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091380AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T20:56:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091380AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091380AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091380AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091380AESEQ2 AERELTXTEvent Due to Other Specify wisdom teeth removal CRF C4591001AEC4591001 1009 10091380AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091380AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091380AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-24T09:04:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091382AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091382AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091382AESEQ1 AERELTXTEvent Due to Other Specify DANCING OVERUSE CRF C4591001AEC4591001 1009 10091382AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091382AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-08T22:08:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091382AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091382AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091382AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091382AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-15T18:42:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091382AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091382AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091382AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091382AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-13T23:16:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091382AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091382AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091382AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091382AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-13T23:15:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091382AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091382AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091382AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091382AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-13T23:16:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091382AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091382AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091382AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091382AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091382AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-13T23:16:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091399AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091399AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091399AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091399AESEQ1 AERELTXTEvent Due to Other Specify Injury CRF C4591001AEC4591001 1009 10091399AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091399AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091399AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T20:10:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091400AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091400AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091400AESEQ1 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1009 10091400AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091400AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-23T19:21:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091400AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091400AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091400AESEQ2 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1009 10091400AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091400AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-23T19:22:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091400AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091401AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091401AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091401AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091401AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1009 10091401AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091401AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091401AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-23T18:40:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091403AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091403AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091403AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091403AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091403AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091403AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-02T00:45:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091404AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091404AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091405AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091405AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091405AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091405AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-23T21:20:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091405AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091405AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091405AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091405AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-23T21:21:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091405AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091405AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091405AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091405AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ3 LSTCGDTCDate/Time of Last change 2021-08-23T21:21:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091405AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091405AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091405AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091405AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091405AESEQ4 LSTCGDTCDate/Time of Last change 2021-08-23T21:20:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091406AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091406AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091406AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091406AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-23T21:20:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091406AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091406AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091406AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091406AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-24T15:12:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091406AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091406AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091406AESEQ3 AERELTXTEvent Due to Other Specify activity related, exercise CRF C4591001AEC4591001 1009 10091406AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091406AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-09T20:45:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091406AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091406AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091406AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091406AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091406AESEQ4 LSTCGDTCDate/Time of Last change 2021-08-23T21:20:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091409AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091409AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091409AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091409AESEQ1 AERELTXTEvent Due to Other Specify Developmental-Spinal Fusion Surgery CRF C4591001AEC4591001 1009 10091409AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091409AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091409AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-09T15:38:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091410AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091410AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091410AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091410AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091410AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091410AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-04T18:07:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091410AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1009 10091410AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091410AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091410AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091410AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091410AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-04T18:07:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091411AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091412AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091413AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091413AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1009 10091413AESEQ1 AERELTXTEvent Due to Other Specify Skiing Accident CRF C4591001AEC4591001 1009 10091413AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091413AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-08T08:33:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091413AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091413AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091413AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091413AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-05T18:00:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1009 10091413AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1009 10091413AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1009 10091413AESEQ3 AERELTXTEvent Due to Other Specify Post Surgical pain CRF C4591001AEC4591001 1009 10091413AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1009 10091413AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-09T19:57:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1009 10091413AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131824AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1013 10131824AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1013 10131824AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1013 10131824AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1013 10131824AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131824AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-22T23:55:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131828AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131839AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1013 10131839AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1013 10131839AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1013 10131839AESEQ1 AERELTXTEvent Due to Other Specify INJURY CRF C4591001AEC4591001 1013 10131839AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1013 10131839AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131839AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-31T18:21:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131839AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131843AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131843AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131843AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131863AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131878AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1013 10131878AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161307AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161310AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161316AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161316AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161316AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161316AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161316AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161316AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-02T22:52:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161316AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161316AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161316AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161316AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161316AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161316AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-02T22:52:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161319AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161319AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161322AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161327AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161327AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161327AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161327AESEQ1 AERELTXTEvent Due to Other Specify epilepsy-idiopathic CRF C4591001AEC4591001 1016 10161327AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161327AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161327AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-23T09:23:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161327AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161327AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161327AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161327AESEQ2 AERELTXTEvent Due to Other Specify unknown-possible dehydration CRF C4591001AEC4591001 1016 10161327AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161327AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161327AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-26T21:00:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161329AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161329AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161329AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161329AESEQ1 AERELTXTEvent Due to Other Specify bacterial infection secondary to puncture wound CRF C4591001AEC4591001 1016 10161329AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161329AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161329AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-13T16:25:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161329AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161329AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161329AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161329AESEQ2 AERELTXTEvent Due to Other Specify accidental trauma CRF C4591001AEC4591001 1016 10161329AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161329AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161329AESEQ2 LSTCGDTCDate/Time of Last change 2021-09-13T16:24:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161330AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161330AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161344AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161344AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161344AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161344AESEQ1 AERELTXTEvent Due to Other Specify mono infection CRF C4591001AEC4591001 1016 10161344AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161344AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161344AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-05T20:11:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161344AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161344AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161344AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161344AESEQ2 AERELTXTEvent Due to Other Specify mono CRF C4591001AEC4591001 1016 10161344AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161344AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161344AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-05T20:10:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161344AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161353AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-26T23:42:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161353AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T19:34:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161353AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ3 LSTCGDTCDate/Time of Last change 2021-05-26T23:42:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161353AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-16T19:34:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161353AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-12T13:32:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161353AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ6 LSTCGDTCDate/Time of Last change 2021-05-26T23:42:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161353AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-16T19:34:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ8 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161353AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161353AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161353AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161353AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161353AESEQ8 LSTCGDTCDate/Time of Last change 2021-06-16T19:34:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161357AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161365AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161366AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161366AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161366AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161366AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161366AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161366AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-11T19:08:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161367AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161369AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161371AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1016 10161371AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161371AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161371AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161371AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161371AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T13:52:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161371AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1016 10161371AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1016 10161371AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1016 10161371AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1016 10161371AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161371AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T16:15:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161375AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161375AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161382AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1016 10161387AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391246AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391246AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391246AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391246AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-02T18:33:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391246AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391246AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391246AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391246AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-15T21:52:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391246AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391246AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391246AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391246AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ3 LSTCGDTCDate/Time of Last change 2021-03-02T18:34:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391246AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391246AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391246AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391246AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ4 LSTCGDTCDate/Time of Last change 2021-03-02T18:34:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391246AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391246AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391246AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391246AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ5 LSTCGDTCDate/Time of Last change 2021-03-02T18:34:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391246AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391246AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391246AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391246AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391246AESEQ6 LSTCGDTCDate/Time of Last change 2021-04-15T21:52:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391250AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391250AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391250AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391250AESEQ1 AERELTXTEvent Due to Other Specify stress in life CRF C4591001AEC4591001 1039 10391250AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391250AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391250AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-19T20:43:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391251AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391251AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391251AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391251AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391251AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391251AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-29T17:41:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391251AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391251AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391251AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391251AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391251AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391251AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-29T17:41:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391258AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391258AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391258AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391258AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391258AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391258AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T21:28:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391258AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391258AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391258AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391258AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391258AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391258AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T21:28:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391258AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391258AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391258AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391258AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391258AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391258AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-06T21:28:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391259AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391259AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391259AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391259AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-04T21:31:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391259AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391259AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391259AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391259AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-02T21:10:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391259AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391259AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391259AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391259AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-02T21:10:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391259AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391259AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391259AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391259AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-04T21:31:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391259AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391259AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391259AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391259AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-16T19:45:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391259AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391259AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391259AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391259AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391259AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-02T21:09:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391264AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391264AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391264AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391264AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391264AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391264AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T19:39:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391264AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391264AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391264AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391264AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391266AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391266AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391266AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391266AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-08T22:44:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391266AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391266AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391266AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391266AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-09T07:04:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391266AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391266AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391266AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391266AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-09T16:50:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391266AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391266AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391266AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391266AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391266AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-09T19:39:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391267AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391268AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391268AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391268AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391268AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391268AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391268AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T13:46:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391270AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391270AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391270AESEQ1 AERELTXTEvent Due to Other Specify dry mucus membranes CRF C4591001AEC4591001 1039 10391270AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391270AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T14:58:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391270AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391270AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391270AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391270AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T16:54:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391270AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391270AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391270AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391270AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-01T16:11:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391270AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391270AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391270AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391270AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-08T19:10:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391270AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391270AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391270AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391270AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-08T19:10:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391270AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391270AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391270AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391270AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-01T16:11:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391270AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391271AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391271AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391271AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391271AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391271AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391271AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T18:38:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391271AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391271AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391271AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391271AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391271AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391271AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-14T20:18:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391273AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391273AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391273AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391273AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391273AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391273AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T18:38:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391273AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391273AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391273AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391273AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391273AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391273AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T14:35:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391274AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391274AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391274AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391274AESEQ1 AERELTXTEvent Due to Other Specify allergies CRF C4591001AEC4591001 1039 10391274AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391274AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391274AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-07T08:14:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391274AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391274AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391274AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391274AESEQ2 AERELTXTEvent Due to Other Specify allergies CRF C4591001AEC4591001 1039 10391274AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391274AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391274AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T23:25:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391279AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391279AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391279AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391279AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T20:19:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391279AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391279AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1039 10391279AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391279AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-14T20:18:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391279AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391279AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391279AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391279AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-07T20:55:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391279AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391279AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391279AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391279AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-06T19:27:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391279AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391279AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391279AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391279AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-07T20:55:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391279AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391279AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391279AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391279AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391279AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-06T19:26:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391280AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391280AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391280AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391280AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T16:54:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391280AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391280AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391280AESEQ2 AERELTXTEvent Due to Other Specify Blood draw during visit 3 CRF C4591001AEC4591001 1039 10391280AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391280AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-07T16:54:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391280AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391283AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391283AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391283AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391283AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391283AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391283AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T16:55:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391283AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391283AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391283AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391283AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391283AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391283AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-07T16:55:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391283AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391283AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391283AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391283AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391283AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391283AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-07T16:55:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391284AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-15T18:13:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-04T16:55:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-04T16:56:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-13T19:02:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-04T16:56:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-12T21:49:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391285AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391285AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391285AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391285AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391285AESEQ7 LSTCGDTCDate/Time of Last change 2021-07-12T21:49:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391287AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391287AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391287AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391287AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-17T19:25:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391287AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391287AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391287AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391287AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T21:29:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391287AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391287AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391287AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391287AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-06T21:30:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391287AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391287AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391287AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391287AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-17T19:25:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391287AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391287AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391287AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391287AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391287AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-06T21:30:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391290AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391290AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391290AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391290AESEQ1 AERELTXTEvent Due to Other Specify Blood draw at Visit 4 CRF C4591001AEC4591001 1039 10391290AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391290AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391290AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-13T16:26:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391292AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391292AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391292AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391292AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T16:55:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391292AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391292AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391292AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391292AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T19:27:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391292AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391292AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391292AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391292AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-06T19:27:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391292AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391292AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391292AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391292AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-08T14:27:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391292AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391292AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391292AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391292AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391292AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-06T19:28:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391294AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391294AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391294AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391294AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391294AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391294AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-07T17:33:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391294AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391294AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391294AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391294AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391294AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391294AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-07T16:56:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391294AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391294AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391296AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391296AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391296AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391296AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T22:48:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391296AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391296AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391296AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391296AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-02T16:39:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391296AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391296AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391296AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391296AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-07T16:56:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391296AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391296AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391296AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391296AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-02T16:39:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391296AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391296AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391296AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391296AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391296AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-14T20:19:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391300AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-28T19:05:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-07T16:57:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-13T21:37:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-07T16:57:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-28T19:05:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-07T16:57:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-28T19:05:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ8 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ8 AERELTXTEvent Due to Other Specify blood draw CRF C4591001AEC4591001 1039 10391301AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ8 LSTCGDTCDate/Time of Last change 2021-05-13T18:58:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ9 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391301AESEQ9 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391301AESEQ9 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391301AESEQ9 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391301AESEQ9 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391301AESEQ9 LSTCGDTCDate/Time of Last change 2021-06-28T19:05:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391302AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391303AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391303AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391303AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391303AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391303AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391303AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T17:54:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391305AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391305AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391305AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391305AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391305AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391305AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T16:57:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391307AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ1 AERELTXTEvent Due to Other Specify automimmune disorder CRF C4591001AEC4591001 1039 10391307AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-06T19:28:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391307AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T19:28:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391307AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-06T19:29:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391307AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ4 AERELTXTEvent Due to Other Specify prior injury CRF C4591001AEC4591001 1039 10391307AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-06T21:15:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391307AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-06T19:29:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391307AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-06T19:29:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391307AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ7 AERELTXTEvent Due to Other Specify Incidental finding CRF C4591001AEC4591001 1039 10391307AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ7 LSTCGDTCDate/Time of Last change 2021-07-14T20:31:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ8 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391307AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ8 AERELTXTEvent Due to Other Specify Dietary deficiency CRF C4591001AEC4591001 1039 10391307AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ8 LSTCGDTCDate/Time of Last change 2021-07-15T17:36:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ9 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391307AESEQ9 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ9 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ9 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ9 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ9 LSTCGDTCDate/Time of Last change 2021-07-14T20:31:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ10 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391307AESEQ10 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391307AESEQ10 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391307AESEQ10 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391307AESEQ10 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ10 LSTCGDTCDate/Time of Last change 2021-07-06T19:29:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391307AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391309AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391309AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391309AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391309AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391309AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391309AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:04:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391309AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391309AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391309AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391309AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391309AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391309AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-22T17:12:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391309AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391309AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391309AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391309AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391309AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391309AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-09T00:04:20 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391310AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-07T15:16:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391310AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-06T21:31:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391310AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-17T15:12:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391310AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-06T21:31:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391310AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-11T16:31:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391310AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-06T21:31:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391310AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391310AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391310AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391310AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391310AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-08T16:44:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391313AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391313AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391313AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391313AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T16:51:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391313AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391313AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391313AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391313AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T16:50:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391313AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391313AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391313AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391313AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-07T15:20:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391313AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391313AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391313AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391313AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391313AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-08T16:49:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391314AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391314AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391314AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1039 10391314AESEQ1 AERELTXTEvent Due to Other Specify female hormonal changes CRF C4591001AEC4591001 1039 10391314AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391314AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391314AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-17T19:16:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391314AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391314AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391314AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391314AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391314AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391314AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T14:59:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391315AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391315AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391315AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391315AESEQ1 AERELTXTEvent Due to Other Specify Blood draw procedure at visit. CRF C4591001AEC4591001 1039 10391315AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391315AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391315AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-22T21:46:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391317AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391317AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391317AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391317AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-18T19:36:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391317AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391317AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391317AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391317AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-18T19:36:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391317AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391317AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391317AESEQ3 AERELTXTEvent Due to Other Specify blood draw CRF C4591001AEC4591001 1039 10391317AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391317AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-18T19:36:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391317AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391317AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391317AESEQ4 AERELTXTEvent Due to Other Specify blood draw CRF C4591001AEC4591001 1039 10391317AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391317AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391317AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-18T19:36:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391318AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391318AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391319AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391319AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391319AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391319AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391319AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391319AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-03T14:15:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391319AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391319AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391319AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391319AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391319AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391319AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-03T14:16:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391319AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391319AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391319AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391319AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391319AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391319AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-03T14:14:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391320AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391320AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391321AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391321AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391321AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391321AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391321AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391321AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T21:15:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391321AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391321AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391321AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391321AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391321AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391321AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-15T21:20:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391324AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391325AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T18:38:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391325AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-17T20:13:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391325AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-08T16:44:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391325AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-06T17:54:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391325AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-17T20:13:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391325AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ6 LSTCGDTCDate/Time of Last change 2021-06-15T15:25:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391325AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-17T20:13:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ8 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391325AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391325AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391325AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391325AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391325AESEQ8 LSTCGDTCDate/Time of Last change 2021-06-07T20:45:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391326AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391326AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391326AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1039 10391326AESEQ1 AERELTXTEvent Due to Other Specify Stress and inadequate medication CRF C4591001AEC4591001 1039 10391326AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391326AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391326AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-18T13:54:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391326AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391326AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391326AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1039 10391326AESEQ2 AERELTXTEvent Due to Other Specify Stress CRF C4591001AEC4591001 1039 10391326AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391326AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391326AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-12T17:29:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391327AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391327AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391327AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391327AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391327AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391327AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-23T13:35:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391328AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391328AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391328AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391328AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-15T18:00:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391328AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391328AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391328AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391328AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-17T23:59:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391328AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391328AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391328AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391328AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-08T22:45:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391328AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391328AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391328AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391328AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-17T20:16:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391328AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391329AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391329AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391329AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391329AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391329AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391329AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T20:10:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391329AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391329AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391329AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391329AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391329AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391329AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T21:14:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391329AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391329AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391329AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391329AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391329AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391329AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-09T20:10:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391330AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391330AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391330AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391330AESEQ1 AERELTXTEvent Due to Other Specify food CRF C4591001AEC4591001 1039 10391330AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391330AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391330AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-30T18:53:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391330AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391330AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391330AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391330AESEQ2 AERELTXTEvent Due to Other Specify food CRF C4591001AEC4591001 1039 10391330AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391330AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391330AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-30T18:54:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391330AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391330AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391332AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391332AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391332AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1039 10391332AESEQ1 AERELTXTEvent Due to Other Specify Inadequate Medication treatment for depression CRF C4591001AEC4591001 1039 10391332AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391332AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391332AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-26T15:18:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391333AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391333AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391333AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391333AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391333AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391333AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T17:19:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391336AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391336AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391337AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391337AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391337AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391337AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-17T23:57:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391337AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391337AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391337AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391337AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-17T20:47:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391337AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391337AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391337AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391337AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ3 LSTCGDTCDate/Time of Last change 2021-02-09T19:32:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1039 10391337AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391337AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391337AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391337AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391337AESEQ4 LSTCGDTCDate/Time of Last change 2021-05-18T19:26:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391339AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391339AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391339AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391339AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391339AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391339AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:05:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391339AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1039 10391339AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1039 10391339AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1039 10391339AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1039 10391339AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1039 10391339AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T02:53:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441251AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441251AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441251AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441251AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441251AESEQ194000000005DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441251AESEQ194000000006DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441255AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441255AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441261AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441264AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441265AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441265AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441265AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441265AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441265AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441265AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441265AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T20:57:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441266AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441266AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441266AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441266AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441266AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441266AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441266AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-28T22:58:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441267AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441267AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441267AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441267AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441267AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441267AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441267AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T20:59:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441267AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441267AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441267AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441267AESEQ2 AERELTXTEvent Due to Other Specify accidental fall CRF C4591001AEC4591001 1044 10441267AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441267AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441267AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T20:50:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441275AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441275AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441275AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441275AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441275AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441275AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-29T23:53:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441282AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441282AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441282AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441282AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441282AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441282AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-21T23:28:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441282AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441282AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441284AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441284AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441284AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441284AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441284AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441284AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441284AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-14T21:56:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441284AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441284AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441284AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441284AESEQ2 AERELTXTEvent Due to Other Specify med history CRF C4591001AEC4591001 1044 10441284AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441284AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441284AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-14T21:56:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441285AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441285AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441285AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441285AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441285AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441285AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441285AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T12:06:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441292AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441292AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441292AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441292AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441292AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441292AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441292AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-06T10:52:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441300AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441300AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441300AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441300AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441300AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441300AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441300AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-07T12:48:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441302AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441302AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441303AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441303AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441303AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441303AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441303AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441303AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-14T20:55:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441303AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441303AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441303AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441303AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441303AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441303AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-18T08:15:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441304AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441304AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441304AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441304AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441304AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441304AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441304AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-27T00:34:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441309AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441309AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441309AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441309AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441309AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441309AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441309AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-16T20:05:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441320AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441320AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441320AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441320AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441320AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441320AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-03T11:09:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441320AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441320AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441320AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441320AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441320AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441320AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-03T11:08:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441328AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441328AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441328AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1044 10441328AESEQ1 AERELTXTEvent Due to Other Specify UNKNOWN ETIOLOGY CRF C4591001AEC4591001 1044 10441328AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441328AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441328AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-29T15:50:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441330AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441335AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441335AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441335AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441335AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441335AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441335AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441335AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-05T23:58:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441337AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441337AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441337AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441337AESEQ1 AERELTXTEvent Due to Other Specify accident CRF C4591001AEC4591001 1044 10441337AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441337AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441337AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-19T19:28:20 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441338AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441338AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441338AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441338AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441338AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441338AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441338AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-26T19:49:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441343AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441343AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441345AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441345AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441345AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441345AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T21:16:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441345AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441345AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441345AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441345AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-08T21:16:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441345AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441345AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441345AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441345AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-08T21:16:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441345AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441345AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441345AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441345AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441345AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-08T21:16:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441350AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441350AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441351AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441351AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441351AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441351AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441351AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441351AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441351AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-04T22:57:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441354AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441354AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441354AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441354AESEQ1 AERELTXTEvent Due to Other Specify med history CRF C4591001AEC4591001 1044 10441354AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441354AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441354AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-14T22:46:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441359AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441361AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441361AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441361AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441361AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441361AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441361AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441361AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-09T19:56:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441361AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441361AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441361AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441361AESEQ2 AERELTXTEvent Due to Other Specify (contact with poison sumac) CRF C4591001AEC4591001 1044 10441361AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441361AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441361AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-25T09:46:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441364AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441364AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441364AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441364AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441364AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441364AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441364AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-22T15:38:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441364AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441364AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441364AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441364AESEQ2 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441364AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441364AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441364AESEQ2 LSTCGDTCDate/Time of Last change 2021-09-17T15:09:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441364AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441364AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441364AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441364AESEQ3 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441364AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441364AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441364AESEQ3 LSTCGDTCDate/Time of Last change 2021-09-17T15:09:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441373AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441373AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441373AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441373AESEQ1 AERELTXTEvent Due to Other Specify medication dosage adjustment CRF C4591001AEC4591001 1044 10441373AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441373AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441373AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-11T18:39:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441373AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1044 10441373AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441373AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441373AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441373AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441373AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-04T21:49:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441379AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441379AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441379AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441384AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441384AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441384AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441384AESEQ1 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441384AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441384AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441384AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T02:56:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441384AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1044 10441384AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1044 10441384AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1044 10441384AESEQ2 AERELTXTEvent Due to Other Specify unk CRF C4591001AEC4591001 1044 10441384AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1044 10441384AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1044 10441384AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-02T08:36:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571377AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571378AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571378AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571382AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571382AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571382AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571383AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571387AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571387AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571387AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571387AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571387AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571387AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-04T17:32:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571387AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571388AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571388AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571388AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571389AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571389AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571389AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571389AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571389AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571389AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-24T18:57:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571389AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571389AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571389AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571389AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571389AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571389AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-24T21:23:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571393AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000005DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000006DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000007DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571394AESEQ194000000008DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571398AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571399AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571399AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571403AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571403AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571404AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571404AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571407AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571407AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571407AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571407AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571407AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571407AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-30T18:14:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571407AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571407AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571407AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571407AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571407AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571407AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-30T18:08:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571408AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571408AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571408AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571408AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571408AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571408AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T20:56:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571408AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571408AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571408AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571408AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571408AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571408AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T22:11:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571414AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571414AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571414AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571414AESEQ194000000004DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571417AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571417AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571424AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571424AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571424AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571428AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571428AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571431AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571431AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571431AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571431AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571431AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571431AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-20T16:22:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571432AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571432AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571432AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571432AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571432AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571432AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-01T16:12:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571432AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571432AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571432AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571432AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571432AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571432AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-01T16:12:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571433AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571434AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571434AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571434AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571434AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571434AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571434AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-04T17:28:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571434AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571434AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571434AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571434AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571434AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571434AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-04T17:28:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571441AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1057 10571441AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571441AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571441AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571441AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571441AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T17:18:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571448AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571451AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1057 10571451AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1057 10571451AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1057 10571451AESEQ1 AERELTXTEvent Due to Other Specify HISTORY OF RECURRENT YEAST INFECTIONS CRF C4591001AEC4591001 1057 10571451AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1057 10571451AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571451AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-31T14:32:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571451AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571452AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571454AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1057 10571454AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661405AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661409AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661409AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661410AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1066 10661410AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1066 10661410AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1066 10661410AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1066 10661410AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661410AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T03:44:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661410AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661415AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661415AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661415AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661416AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661416AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661416AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661417AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661419AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661419AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661419AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661421AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661421AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661422AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1066 10661422AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1066 10661422AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1066 10661422AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1066 10661422AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1066 10661422AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661422AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-31T18:06:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661423AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661424AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1066 10661424AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771275AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771275AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771275AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771275AESEQ1 AERELTXTEvent Due to Other Specify ACCIDENTAL MECHANICAL FALL CRF C4591001AEC4591001 1077 10771275AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771275AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771275AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T20:54:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771275AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1077 10771275AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771275AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771275AESEQ2 AERELTXTEvent Due to Other Specify ACCIDENTAL MECHANICAL FALL CRF C4591001AEC4591001 1077 10771275AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771275AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771275AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-07T20:54:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771278AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-16T00:38:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771278AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ2 LSTCGDTCDate/Time of Last change 2021-01-16T00:39:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771278AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ3 LSTCGDTCDate/Time of Last change 2021-01-16T00:39:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771278AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ4 LSTCGDTCDate/Time of Last change 2021-01-16T03:50:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771278AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ5 LSTCGDTCDate/Time of Last change 2021-01-16T03:50:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1077 10771278AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ6 LSTCGDTCDate/Time of Last change 2021-01-16T03:50:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771278AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771278AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771278AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771278AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771278AESEQ7 LSTCGDTCDate/Time of Last change 2021-01-16T03:50:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771279AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771279AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771279AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771279AESEQ1 AERELTXTEvent Due to Other Specify BLUNT TRAUMA CRF C4591001AEC4591001 1077 10771279AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771279AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771279AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-30T21:02:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771279AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771279AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771279AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771279AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771279AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771279AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-19T23:00:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771280AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771280AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771280AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771280AESEQ1 AERELTXTEvent Due to Other Specify ACCIDENTAL MECHANICAL FALL CRF C4591001AEC4591001 1077 10771280AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771280AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771280AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-18T16:08:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771280AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771280AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771280AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771280AESEQ2 AERELTXTEvent Due to Other Specify ACCIDENTAL MECHANICAL FALL CRF C4591001AEC4591001 1077 10771280AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771280AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771280AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-19T15:25:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771285AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1077 10771285AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771285AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771285AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771285AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771285AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-07T20:55:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771290AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771295AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771295AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771295AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1077 10771295AESEQ1 AERELTXTEvent Due to Other Specify TEAM MATE ACCIDENTALY FELL ON HIM CRF C4591001AEC4591001 1077 10771295AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771295AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771295AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-23T17:04:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771295AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771295AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771295AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771295AESEQ2 AERELTXTEvent Due to Other Specify FOOTBALL INJURY CRF C4591001AEC4591001 1077 10771295AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771295AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771295AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-23T17:56:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771295AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771295AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771295AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771295AESEQ3 AERELTXTEvent Due to Other Specify TEAMMATE ACCIDENTALLY FELL ON HIM CRF C4591001AEC4591001 1077 10771295AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771295AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771295AESEQ3 LSTCGDTCDate/Time of Last change 2021-05-03T23:44:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771298AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771298AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771298AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771298AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771298AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771298AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-07T15:56:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771300AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1077 10771300AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1077 10771300AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1077 10771300AESEQ1 AERELTXTEvent Due to Other Specify UNABLE TO PROVE CAUSALITY CRF C4591001AEC4591001 1077 10771300AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1077 10771300AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1077 10771300AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-02T19:08:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841543AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1084 10841543AESEQ1 AEMEFL Medication Error Associated With AE N CRF C4591001AEC4591001 1084 10841543AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1084 10841543AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1084 10841543AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841543AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-17T05:35:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841546AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841546AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841556AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1084 10841556AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1084 10841556AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1084 10841556AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1084 10841556AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1084 10841556AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841556AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-23T04:11:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841557AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841558AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1084 10841558AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1084 10841558AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1084 10841558AESEQ1 AERELTXTEvent Due to Other Specify fall CRF C4591001AEC4591001 1084 10841558AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1084 10841558AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841558AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-11T20:58:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841560AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1084 10841560AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1084 10841560AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1084 10841560AESEQ1 AERELTXTEvent Due to Other Specify new neuro diagnosis CRF C4591001AEC4591001 1084 10841560AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1084 10841560AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841560AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T00:48:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841561AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841563AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841569AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1084 10841569AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1084 10841569AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1084 10841569AESEQ1 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1084 10841569AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1084 10841569AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1084 10841569AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T17:19:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911400AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911406AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911406AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911406AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911406AESEQ1 AERELTXTEvent Due to Other Specify Social/environmental events CRF C4591001AEC4591001 1091 10911406AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911406AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911406AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-15T17:49:24 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911406AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911406AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911406AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1091 10911406AESEQ2 AERELTXTEvent Due to Other Specify Sports injury CRF C4591001AEC4591001 1091 10911406AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911406AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911406AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-15T19:21:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911409AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911411AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911411AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911411AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911411AESEQ1 AERELTXTEvent Due to Other Specify tooth impaction CRF C4591001AEC4591001 1091 10911411AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911411AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911411AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-03T08:21:07 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911412AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911414AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911414AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911414AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911414AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911414AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911414AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-04T17:28:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911417AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911417AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911417AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911417AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911417AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911417AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-15T16:36:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911417AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1091 10911417AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911417AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911417AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911417AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911417AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-15T16:35:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911422AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1091 10911422AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911422AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911422AESEQ1 AERELTXTEvent Due to Other Specify bacterial infection CRF C4591001AEC4591001 1091 10911422AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911422AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911422AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-04T17:33:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911422AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1091 10911422AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911422AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911422AESEQ2 AERELTXTEvent Due to Other Specify bacterial infection CRF C4591001AEC4591001 1091 10911422AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911422AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911422AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-04T17:31:20 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911422AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1091 10911422AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911422AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911422AESEQ3 AERELTXTEvent Due to Other Specify bacterial infection CRF C4591001AEC4591001 1091 10911422AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911422AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911422AESEQ3 LSTCGDTCDate/Time of Last change 2021-02-04T17:31:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911423AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911423AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911423AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911423AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-23T19:54:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911423AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911423AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911423AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911423AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-23T19:54:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911423AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911423AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911423AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911423AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ3 LSTCGDTCDate/Time of Last change 2021-08-27T20:11:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911423AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911423AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911423AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911423AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911423AESEQ4 LSTCGDTCDate/Time of Last change 2021-08-23T19:54:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911432AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911433AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911433AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911433AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1091 10911433AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1091 10911433AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911433AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911433AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-10T22:48:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911433AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911440AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911440AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911441AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911441AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911441AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911447AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911447AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911447AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1091 10911447AESEQ1 AERELTXTEvent Due to Other Specify Appendicitis CRF C4591001AEC4591001 1091 10911447AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911447AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911447AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-07T12:17:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911457AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911463AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1091 10911463AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1091 10911463AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1091 10911463AESEQ1 AERELTXTEvent Due to Other Specify dental impaction CRF C4591001AEC4591001 1091 10911463AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1091 10911463AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911463AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T16:40:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1091 10911466AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231422AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231422AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231428AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231428AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231428AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231434AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231439AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231439AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231440AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231440AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231440AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231440AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231440AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231440AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231440AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-30T16:08:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231442AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231442AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231442AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231442AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231442AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T19:15:00 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231442AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231442AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231442AESEQ2 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231442AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231442AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T20:43:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231442AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231442AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231442AESEQ3 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231442AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231442AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ3 LSTCGDTCDate/Time of Last change 2021-05-19T15:03:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231442AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231448AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1123 11231448AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231448AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231448AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231448AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231448AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-21T18:14:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231449AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231452AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231456AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231456AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231472AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231472AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231472AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231472AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231472AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231472AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231472AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-23T21:14:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231472AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231472AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231472AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231472AESEQ2 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231472AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231472AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231472AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-09T15:47:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231473AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231473AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231473AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1123 11231473AESEQ1 AERELTXTEvent Due to Other Specify Sports Injury CRF C4591001AEC4591001 1123 11231473AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231473AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231473AESEQ1 LSTCGDTCDate/Time of Last change 2021-05-28T16:34:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231475AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231475AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231489AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231489AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231489AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231489AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231489AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231489AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231489AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T18:55:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231494AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231505AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231507AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231507AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231507AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231507AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231507AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231507AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231507AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-22T15:47:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231507AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231507AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231507AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231507AESEQ2 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231507AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231507AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231507AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-24T21:20:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231507AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231508AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231520AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1123 11231520AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231520AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231520AESEQ1 AERELTXTEvent Due to Other Specify unknown CRF C4591001AEC4591001 1123 11231520AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231520AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231520AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-23T20:06:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231523AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1123 11231523AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1123 11231523AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1123 11231523AESEQ1 AERELTXTEvent Due to Other Specify UNKNOWN CRF C4591001AEC4591001 1123 11231523AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1123 11231523AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231523AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-09T17:49:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1123 11231526AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241236AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241236AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241240AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241245AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1124 11241245AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1124 11241245AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1124 11241245AESEQ1 AERELTXTEvent Due to Other Specify Mood disorder CRF C4591001AEC4591001 1124 11241245AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1124 11241245AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241245AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-16T12:36:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241245AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1124 11241245AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1124 11241245AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1124 11241245AESEQ2 AERELTXTEvent Due to Other Specify mood disorder CRF C4591001AEC4591001 1124 11241245AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1124 11241245AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241245AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-16T12:37:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241251AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1124 11241251AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1124 11241251AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1124 11241251AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1124 11241251AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1124 11241251AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-26T18:38:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1125 11251248AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1125 11251248AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1125 11251248AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1125 11251248AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1125 11251248AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1125 11251248AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-19T20:09:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1125 11251248AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1125 11251255AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261233AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261233AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261233AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261233AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-12T00:31:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261233AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261233AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261233AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261233AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-09T03:44:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261233AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261233AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261233AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261233AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-12T00:31:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261233AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261233AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261233AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261233AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261233AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-12T00:31:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261235AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261235AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261235AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261235AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261235AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261235AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T21:47:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261235AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261235AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261235AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1126 11261235AESEQ2 AERELTXTEvent Due to Other Specify Doxycycline CRF C4591001AEC4591001 1126 11261235AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261235AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261235AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T23:02:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261235AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261235AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261235AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261235AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261235AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261235AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-12T21:47:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261239AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261239AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261239AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261239AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T22:49:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261239AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261239AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261239AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261239AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T00:01:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261239AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261239AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261239AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261239AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-15T00:51:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261239AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261239AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261239AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261239AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-14T22:49:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261239AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261239AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261239AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261239AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-14T22:49:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261239AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261240AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261240AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261240AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261240AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-14T22:49:39 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261240AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261240AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261240AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261240AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T16:15:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261240AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261240AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261240AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261240AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-14T22:49:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261240AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261240AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261240AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261240AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261240AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-14T22:50:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261246AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261246AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261246AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261246AESEQ1 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1126 11261246AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261246AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261246AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-26T02:35:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261246AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261246AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261246AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261246AESEQ2 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1126 11261246AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261246AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261246AESEQ2 LSTCGDTCDate/Time of Last change 2021-05-03T18:41:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261246AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261246AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261246AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261246AESEQ3 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1126 11261246AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261246AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261246AESEQ3 LSTCGDTCDate/Time of Last change 2021-01-26T02:35:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261250AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261250AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261250AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261250AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261250AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261250AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-20T13:05:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261250AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261250AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261250AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261250AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261250AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261250AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-18T03:03:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261250AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261250AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261250AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261250AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261250AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261250AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-20T13:05:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261253AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261253AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261253AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261253AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:02:20 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261253AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261253AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261253AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261253AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T00:02:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261253AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261253AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261253AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261253AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-09T18:49:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261253AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261253AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261253AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261253AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-09T00:02:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261253AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261253AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261253AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261253AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261253AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-09T00:01:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261254AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T23:49:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261254AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-13T20:24:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261254AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ3 AERELTXTEvent Due to Other Specify Exposure to nuts CRF C4591001AEC4591001 1126 11261254AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ3 LSTCGDTCDate/Time of Last change 2021-01-27T22:15:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261254AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-12T23:49:20 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261254AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ5 LSTCGDTCDate/Time of Last change 2021-08-13T20:24:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261254AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-12T23:49:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261254AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261254AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261254AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261254AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261254AESEQ7 LSTCGDTCDate/Time of Last change 2021-07-12T23:49:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261262AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261262AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261262AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261262AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-01T23:21:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261262AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261262AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261262AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261262AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-01T23:22:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261262AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261262AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261262AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261262AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ3 LSTCGDTCDate/Time of Last change 2021-03-05T19:02:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261262AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261262AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261262AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261262AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261262AESEQ4 LSTCGDTCDate/Time of Last change 2021-04-01T23:21:45 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261263AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261263AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261263AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261263AESEQ1 AERELTXTEvent Due to Other Specify Snow boarding CRF C4591001AEC4591001 1126 11261263AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261263AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261263AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-06T02:26:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261263AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261263AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261263AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261263AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261263AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261263AESEQ2 LSTCGDTCDate/Time of Last change 2020-12-30T21:08:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261263AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261263AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261263AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261263AESEQ3 AERELTXTEvent Due to Other Specify MECHANICAL FALL CRF C4591001AEC4591001 1126 11261263AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261263AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261263AESEQ3 LSTCGDTCDate/Time of Last change 2021-02-23T16:35:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261265AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261265AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261265AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261265AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261265AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261265AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T16:15:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261265AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261265AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261265AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261265AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261265AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261265AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T23:49:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261266AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261266AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261266AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261266AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261266AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261266AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T16:15:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261266AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261266AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261266AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261266AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261266AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261266AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T23:50:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261267AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261267AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261267AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261267AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T17:47:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261267AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261267AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261267AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261267AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-30T00:15:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261267AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261267AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261267AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261267AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-16T17:47:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261267AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261267AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261267AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261267AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ4 LSTCGDTCDate/Time of Last change 2021-08-03T07:25:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261267AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261267AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261267AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261267AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ5 LSTCGDTCDate/Time of Last change 2021-08-03T07:25:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261267AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261267AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261267AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261267AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261267AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-12T23:50:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261268AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261268AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261268AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1126 11261268AESEQ1 AERELTXTEvent Due to Other Specify Gymnastic injury CRF C4591001AEC4591001 1126 11261268AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261268AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261268AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-10T08:58:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261268AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261268AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261268AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261268AESEQ2 AERELTXTEvent Due to Other Specify Trigger unknown CRF C4591001AEC4591001 1126 11261268AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261268AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261268AESEQ2 LSTCGDTCDate/Time of Last change 2021-01-13T00:18:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261269AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261269AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261269AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261270AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261270AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261270AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261270AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261270AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261270AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T21:48:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261270AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261270AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261270AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261270AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261270AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261270AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T16:15:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261271AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261271AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261271AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261271AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261271AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261271AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-20T17:37:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261274AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261274AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261274AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261274AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261274AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261274AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T17:49:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261274AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261274AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261274AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261274AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261274AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261274AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T17:48:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261274AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261274AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261274AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261274AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261274AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261274AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-15T00:51:20 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261275AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261275AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261275AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261275AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261275AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261275AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-05T19:02:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261275AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261275AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261275AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261275AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261275AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261275AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-05T19:02:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261275AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261275AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261275AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261275AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261275AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261275AESEQ3 LSTCGDTCDate/Time of Last change 2021-03-05T19:03:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261276AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261276AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261276AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261276AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-05T19:03:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261276AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261276AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261276AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261276AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-08T02:20:09 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261276AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261276AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261276AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261276AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ3 LSTCGDTCDate/Time of Last change 2021-03-05T19:03:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261276AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261276AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261276AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261276AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ4 LSTCGDTCDate/Time of Last change 2021-04-08T02:19:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261276AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261276AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261276AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261276AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261276AESEQ5 LSTCGDTCDate/Time of Last change 2021-03-05T19:03:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261279AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261279AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261279AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261279AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T17:48:17 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261279AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261279AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261279AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261279AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T21:48:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261279AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261279AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261279AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261279AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-16T17:48:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261279AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261279AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261279AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261279AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-12T21:48:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261279AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261279AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261279AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261279AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261279AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-12T21:48:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261280AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261280AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261280AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261280AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T21:48:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261280AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261280AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261280AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261280AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T17:48:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261280AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261280AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261280AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261280AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-16T17:48:29 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261280AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261280AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261280AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261280AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-12T21:49:12 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261280AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261280AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261280AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261280AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261280AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-12T21:49:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261283AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261283AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261283AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261283AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-14T21:28:58 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261283AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261283AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261283AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261283AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-09T03:44:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261283AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261283AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261283AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261283AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-12T00:33:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261283AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261283AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261283AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261283AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261283AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-12T00:33:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261284AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261284AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261284AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261284AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:03:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261284AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261284AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261284AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261284AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T00:02:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261284AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261284AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261284AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261284AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-12T23:50:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261284AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261284AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261284AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261284AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261284AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-09T00:02:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261287AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261287AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261287AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261287AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261287AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261287AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-12T00:31:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261287AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261287AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261287AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261287AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261287AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261287AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T21:49:23 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261287AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261287AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261287AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261287AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261287AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261287AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-12T21:49:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261289AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261289AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261289AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261289AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261289AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261289AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-12T00:32:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261289AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261289AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261289AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261289AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261289AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261289AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-12T00:32:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261289AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261290AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261290AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261290AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261290AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-12T00:32:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261290AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261290AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261290AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261290AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-12T00:31:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261290AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261290AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261290AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261290AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-21T19:13:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261290AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261290AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261290AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261290AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-12T00:32:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261290AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261290AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261290AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261290AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-21T19:13:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261290AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261290AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261290AESEQ6 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1126 11261290AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261290AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261290AESEQ6 LSTCGDTCDate/Time of Last change 2021-02-03T19:11:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261292AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:03:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261292AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T21:50:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261292AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-09T00:03:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261292AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-19T22:40:06 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261292AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-09T00:03:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261292AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ6 LSTCGDTCDate/Time of Last change 2021-07-12T21:50:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ7 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261292AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ7 LSTCGDTCDate/Time of Last change 2021-06-09T00:03:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ8 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261292AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ8 LSTCGDTCDate/Time of Last change 2021-06-09T00:03:48 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ9 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261292AESEQ9 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ9 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ9 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ9 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ9 LSTCGDTCDate/Time of Last change 2021-07-12T21:50:56 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ10 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261292AESEQ10 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261292AESEQ10 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261292AESEQ10 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261292AESEQ10 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261292AESEQ10 LSTCGDTCDate/Time of Last change 2021-07-12T21:50:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261294AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261294AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261294AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261294AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261294AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261294AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-10T23:37:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261294AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261294AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261294AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261294AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261294AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261294AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-10T23:37:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261294AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261294AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261294AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261294AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261294AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261294AESEQ3 LSTCGDTCDate/Time of Last change 2021-09-14T01:00:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261296AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261296AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1126 11261296AESEQ1 AERELTXTEvent Due to Other Specify Fall from dirt bike CRF C4591001AEC4591001 1126 11261296AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261296AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-10T08:58:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261296AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261296AESEQ2 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1126 11261296AESEQ2 AERELTXTEvent Due to Other Specify Fall from dirt bike CRF C4591001AEC4591001 1126 11261296AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261296AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-10T01:08:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261296AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261296AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261296AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261296AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-01T23:34:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261296AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261296AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261296AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261296AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ4 LSTCGDTCDate/Time of Last change 2021-05-01T13:40:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261296AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261296AESEQ5 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1126 11261296AESEQ5 AERELTXTEvent Due to Other Specify Fall from dirt bike CRF C4591001AEC4591001 1126 11261296AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261296AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ5 LSTCGDTCDate/Time of Last change 2021-02-10T01:08:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ6 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261296AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261296AESEQ6 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1126 11261296AESEQ6 AERELTXTEvent Due to Other Specify Fall from dirt bike CRF C4591001AEC4591001 1126 11261296AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261296AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261296AESEQ6 LSTCGDTCDate/Time of Last change 2021-02-10T18:17:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261297AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261297AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261297AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261297AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261297AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261297AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-20T13:05:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261297AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261297AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261297AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261297AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261297AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261297AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-12T00:32:55 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261300AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261300AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261300AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261300AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261300AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261300AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-16T17:49:16 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261300AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261300AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261300AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261300AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261300AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261300AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T23:50:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261301AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261301AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261301AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261301AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261301AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261301AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-18T22:47:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261302AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261302AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261302AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261302AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261302AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261302AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T21:50:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261302AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261302AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261302AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261302AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261302AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261302AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-16T17:49:28 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261305AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261305AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261305AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261305AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261305AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261305AESEQ1 LSTCGDTCDate/Time of Last change 2021-04-19T21:47:33 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261305AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261305AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261305AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261305AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261305AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261305AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-20T00:30:57 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261306AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261306AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261306AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261306AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261306AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261306AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-08T21:15:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261307AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261307AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261307AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261307AESEQ1 AERELTXTEvent Due to Other Specify Past history of migraine headache CRF C4591001AEC4591001 1126 11261307AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261307AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261307AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-18T20:23:21 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261308AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261308AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261308AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261308AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261308AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261308AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-13T21:10:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261308AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261308AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261308AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261308AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261308AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261308AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-13T06:30:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261309AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261309AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261309AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261309AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261309AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261309AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-02T19:54:37 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261309AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261309AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261309AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261309AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261309AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261309AESEQ2 LSTCGDTCDate/Time of Last change 2021-03-02T18:34:27 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261311AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261311AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261311AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261311AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261311AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261311AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-23T00:01:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261311AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261311AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261311AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261311AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261311AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261311AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-03T08:18:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261312AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261312AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261312AESEQ1 AERELTXTEvent Due to Other Specify Unknown CRF C4591001AEC4591001 1126 11261312AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261312AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ1 LSTCGDTCDate/Time of Last change 2021-01-27T21:44:10 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261312AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261312AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261312AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261312AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T21:13:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261312AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261312AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261312AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261312AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-12T23:51:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261312AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261312AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261312AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261312AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-12T23:51:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261312AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261312AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261312AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261312AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261312AESEQ5 LSTCGDTCDate/Time of Last change 2021-07-12T23:51:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261313AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261314AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261314AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261314AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261314AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-09T00:04:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261314AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261314AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261314AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261314AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-09T00:05:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261314AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261314AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261314AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261314AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-09T00:04:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261314AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261314AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261314AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261314AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-09T00:04:31 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261314AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261314AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261314AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261314AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261314AESEQ5 LSTCGDTCDate/Time of Last change 2021-03-05T20:04:05 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261317AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261317AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261317AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261317AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261317AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261317AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-12T00:33:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261317AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261317AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261317AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261317AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261317AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261317AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-15T00:51:44 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261317AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261317AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261317AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261317AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261317AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261317AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-15T00:51:32 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261318AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261318AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261318AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261318AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261318AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261318AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-26T18:05:08 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261318AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261318AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261318AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261318AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261318AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261318AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-26T18:04:53 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261320AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261320AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261320AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261320AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261320AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261320AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-10T21:13:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261320AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261320AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261320AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261320AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261320AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261320AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T21:13:42 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261320AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261320AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261320AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261320AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261320AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261320AESEQ3 LSTCGDTCDate/Time of Last change 2021-07-09T16:49:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261322AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261322AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261322AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261322AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T23:51:36 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261322AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261322AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261322AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261322AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ2 LSTCGDTCDate/Time of Last change 2021-07-12T23:51:59 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261322AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261322AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261322AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261322AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-16T16:16:19 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261322AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261322AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261322AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261322AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261322AESEQ4 LSTCGDTCDate/Time of Last change 2021-07-12T23:51:47 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261325AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261325AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261325AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261325AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-09T20:11:01 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261325AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261325AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261325AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261325AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T21:14:14 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1126 11261325AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261325AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261325AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261325AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-10T21:14:25 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261325AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261325AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261325AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261325AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-10T21:14:46 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1126 11261325AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1126 11261325AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1126 11261325AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1126 11261325AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1126 11261325AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-10T21:14:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311279AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311279AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311279AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311279AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311279AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311279AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-18T00:20:34 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311279AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311279AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311279AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311279AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311279AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311279AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-18T00:20:41 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311280AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311280AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311280AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311280AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311280AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311280AESEQ1 LSTCGDTCDate/Time of Last change 2020-12-21T22:41:11 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311283AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311283AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311283AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311283AESEQ1 AERELTXTEvent Due to Other Specify bacterial skin infection CRF C4591001AEC4591001 1131 11311283AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311283AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311283AESEQ1 LSTCGDTCDate/Time of Last change 2021-02-22T17:51:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311285AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311285AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311285AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311285AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311285AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311285AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-18T17:33:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311285AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311285AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311285AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311285AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311285AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311285AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-18T17:34:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311285AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311285AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311285AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311285AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311285AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311285AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-18T17:33:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311286AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311287AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311287AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311287AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311287AESEQ1 AERELTXTEvent Due to Other Specify infection CRF C4591001AEC4591001 1131 11311287AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311287AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311287AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-03T08:16:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311287AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311287AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311287AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311287AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311287AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311287AESEQ2 LSTCGDTCDate/Time of Last change 2021-02-17T19:56:40 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311287AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311287AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311287AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311287AESEQ3 AERELTXTEvent Due to Other Specify unknown viral exposure CRF C4591001AEC4591001 1131 11311287AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311287AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311287AESEQ3 LSTCGDTCDate/Time of Last change 2021-02-15T18:15:18 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ1 AERELTXTEvent Due to Other Specify non cardiac CRF C4591001AEC4591001 1131 11311288AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-03T08:17:38 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ2 AERELTXTEvent Due to Other Specify strep CRF C4591001AEC4591001 1131 11311288AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-03T08:18:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ3 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ3 AERELTXTEvent Due to Other Specify strep CRF C4591001AEC4591001 1131 11311288AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ3 LSTCGDTCDate/Time of Last change 2021-08-03T08:17:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ4 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ4 AERELTXTEvent Due to Other Specify strep CRF C4591001AEC4591001 1131 11311288AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ4 LSTCGDTCDate/Time of Last change 2021-08-03T08:17:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ5 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ5 AERELTXTEvent Due to Other Specify infection CRF C4591001AEC4591001 1131 11311288AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ5 LSTCGDTCDate/Time of Last change 2021-08-03T08:16:52 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ6 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ6 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ6 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ6 AERELTXTEvent Due to Other Specify infection CRF C4591001AEC4591001 1131 11311288AESEQ6 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ6 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ6 LSTCGDTCDate/Time of Last change 2021-08-03T08:17:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ7 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ7 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ7 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ7 AERELTXTEvent Due to Other Specify strep CRF C4591001AEC4591001 1131 11311288AESEQ7 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ7 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ7 LSTCGDTCDate/Time of Last change 2021-08-03T08:17:26 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ8 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311288AESEQ8 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311288AESEQ8 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311288AESEQ8 AERELTXTEvent Due to Other Specify strep CRF C4591001AEC4591001 1131 11311288AESEQ8 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311288AESEQ8 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311288AESEQ8 LSTCGDTCDate/Time of Last change 2021-08-03T08:18:02 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311289AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311292AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311292AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311292AESEQ194000000003DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311293AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311293AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311293AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311293AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311293AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311293AESEQ1 LSTCGDTCDate/Time of Last change 2021-08-05T15:10:22 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311293AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311293AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311293AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311293AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311293AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311293AESEQ2 LSTCGDTCDate/Time of Last change 2021-08-05T15:10:35 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311299AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311299AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311299AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311299AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311299AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311299AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-10T19:02:43 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311299AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311299AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311299AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311299AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311299AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311299AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-14T18:29:30 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311299AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311299AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311299AESEQ3 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311299AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311299AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311299AESEQ3 LSTCGDTCDate/Time of Last change 2021-06-21T16:38:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311300AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311300AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311300AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311300AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ1 LSTCGDTCDate/Time of Last change 2021-06-14T16:48:15 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ2 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311300AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311300AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311300AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311300AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ2 LSTCGDTCDate/Time of Last change 2021-06-10T19:02:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ4 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311300AESEQ4 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311300AESEQ4 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311300AESEQ4 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311300AESEQ4 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ4 LSTCGDTCDate/Time of Last change 2021-06-14T16:48:04 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ5 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311300AESEQ5 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311300AESEQ5 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311300AESEQ5 AERELTXTEvent Due to Other Specify excessive sun exposure CRF C4591001AEC4591001 1131 11311300AESEQ5 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311300AESEQ5 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311300AESEQ5 LSTCGDTCDate/Time of Last change 2021-06-10T20:57:03 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311301AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311301AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311301AESEQ1 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1131 11311301AESEQ1 AERELTXTEvent Due to Other Specify accident CRF C4591001AEC4591001 1131 11311301AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311301AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311301AESEQ1 LSTCGDTCDate/Time of Last change 2021-03-31T19:04:50 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311301AESEQ2 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1131 11311301AESEQ2 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311301AESEQ2 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1131 11311301AESEQ2 AERELTXTEvent Due to Other Specify excess exercise CRF C4591001AEC4591001 1131 11311301AESEQ2 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311301AESEQ2 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311301AESEQ2 LSTCGDTCDate/Time of Last change 2021-04-20T17:01:49 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311301AESEQ3 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1131 11311301AESEQ3 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1131 11311301AESEQ3 AENDGIV Was a Non-Drug Treatment given Y CRF C4591001AEC4591001 1131 11311301AESEQ3 AERELTXTEvent Due to Other Specify skiing accident CRF C4591001AEC4591001 1131 11311301AESEQ3 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1131 11311301AESEQ3 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1131 11311301AESEQ3 LSTCGDTCDate/Time of Last change 2021-05-04T16:40:54 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391155AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391171AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1139 11391171AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1139 11391171AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1139 11391171AESEQ1 AERELTXTEvent Due to Other Specify sports injury CRF C4591001AEC4591001 1139 11391171AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1139 11391171AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391171AESEQ1 LSTCGDTCDate/Time of Last change 2021-09-21T21:10:13 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391172AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391172AESEQ194000000002DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391179AESEQ1 AECMGIV Concomitant Medication Given N CRF C4591001AEC4591001 1139 11391179AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1139 11391179AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1139 11391179AESEQ1 AERELTXTEvent Due to Other Specify vasovagal during blood draw CRF C4591001AEC4591001 1139 11391179AESEQ1 AESUBJDCDiscontinued because of this AE N CRF C4591001AEC4591001 1139 11391179AESEQ1 DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391179AESEQ1 LSTCGDTCDate/Time of Last change 2021-07-12T18:45:51 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391189AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391195AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391204AESEQ194000000001DICTVER Dictionary Name and Version MedDRA v24.0 ASSIGNEDCLINICAL STUDY SPONSORC4591001AEC4591001 1139 11391210AESEQ1 AECMGIV Concomitant Medication Given Y CRF C4591001AEC4591001 1139 11391210AESEQ1 AEMERES Is AE a Result of a Medication ErrorN CRF C4591001AEC4591001 1139 11391210AESEQ1 AENDGIV Was a Non-Drug Treatment given N CRF C4591001AEC4591001 1139 11391210AESEQ1 AERELTXTEvent Due to Other Specify sports injury CRF C4591001AEC4591001 1139 11391210AESEQ1 AESUBJDCDiscontinued because of this AE N