Medical Hisotry Analysis Dataset
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
Pooled Age Group 2
Pooled Age Group 2 (N)
Race Specify
Ethnicity
Randomized Population Flag
Safety Population Flag
Full Analysis Set bAb Population Flag
Full Analysis Set nAb Population Flag
Per Protocol bAb Population Flag
Per Protocol nAb Population Flag
Per Protocol bAb Day 29 Flag
Per Protocol bAb Day 57 Flag
Per Protocol bAb Day 209 Flag
Per Protocol nAb Day 29 Flag
Per Protocol nAb Day 57 Flag
Per Protocol nAb Day 209 Flag
First Solicited Safety Population Flag
Second Solicited Safety Population Flag
Solicited Safety Population Flag
FAS nAb 2 Population Flag
PP nAb 2 Population Flag
Per Protocol nAb 2 Day 29 Flag
Per Protocol nAb 2 Day 57 Flag
Per Protocol nAb 2 Day 209 Flag
Deviation Impact bAb Flag
Deviation Impact nAb Flag
Vaccination 1 Flag
Vaccination 2 Flag
Dosing Error Flag
Baseline COVID Infection
Baseline Elecsys SARS CoV-2 Assay
COVID Infection Flag
Sentinel Participant Flag
Day 29 Out of 7-Day Window Flag
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Date of First Exposure in Period 01
Datetime of First Exposure in Period 01
Date of Last Exposure in Period 01
Datetime of Last Exposure in Period 01
Datetime of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of Dose 2
Datetime of Dose 2
Sequence Number
Category for Medical History
Reported Term for the Medical History
Body System or Organ Class
Dictionary-Derived Term
Start Date/Time of Medical History Event
End Date/Time of Medical History Event
End Relative to Reference Time Point
Study Day of Start of Observation
Study Day of End of Observation
Customized Query 01 Name
Customized Query 01 Flag
SMQ 01 Name
SMQ 01 Scope
SMQ 01 Flag
SMQ 02 Name
SMQ 02 Scope
SMQ 02 Flag
SMQ 06 Name
SMQ 06 Scope
SMQ 06 Flag