Adverse Event 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
Link Group ID
Actual Treatment
Actual Treatment (N)
Sponsor-Defined Identifier
Sequence Number
Category for Adverse Event
Reported Term for the Adverse Event
Dictionary-Derived Term
Body System or Organ Class
Body System or Organ Class Code
Lowest Level Term
Lowest Level Term Code
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Primary System Organ Class
Primary System Organ Class Code
Start Date/Time of Adverse Event
End Date/Time of Adverse Event
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
End Relative to Reference Period
Analysis Start Date
Analysis Start Time
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis Start Relative Day
Analysis End Date
Analysis End Time
Analysis End Date/Time
Stage
Stage (N)
Duration of Adverse Event
Most Recent Dose Reference
Relative Start Day from Most Recent Dose
Relative End Day from Most Recent Dose
Treatment Emergent Analysis Flag
Medically-Attended Flag
AE Through 28 Days Analysis Flag
Leading to Study Discontinuation Flag
Solicited Adverse Reaction?
Serious Event
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Other Medically Important Serious Event
Causality
Relationship to Non-Study Treatment
Analysis Causality
Analysis Causality (N)
Standard Toxicity Grade
Severity/Intensity
Analysis Toxicity Grade
Analysis Toxicity Grade (N)
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Pooled Toxicity Grade Group 1
Pooled Toxicity Grade 1 (N)
Action Taken with Study Treatment
Other Action Taken
Outcome of Adverse Event
Recovered/Resolved with Sequelae,Spec
Hospital Admission Date
Hospital Discharge Date
Admitted to ICU
Duration of Healthcare Encounter
Reference ID
Customized Query 01 Name
Customized Query 01 Flag
Customized Query 02 Name
Customized Query 02 Flag
Customized Query 03 Name
Customized Query 03 Flag
SMQ 01 Name
SMQ 01 Scope
SMQ 01 Flag
SMQ 02 Name
SMQ 02 Scope
SMQ 02 Flag
SMQ 03 Name
SMQ 03 Scope
SMQ 03 Flag
SMQ 04 Name
SMQ 04 Scope
SMQ 04 Flag
SMQ 05 Name
SMQ 05 Scope
SMQ 05 Flag
SMQ 06 Name
SMQ 06 Scope
SMQ 06 Flag
SMQ 07 Name
SMQ 07 Scope
SMQ 07 Flag
SMQ 08 Name
SMQ 08 Scope
SMQ 08 Flag
SMQ 09 Name
SMQ 09 Scope
SMQ 09 Flag
SMQ 10 Name
SMQ 10 Scope
SMQ 10 Flag
SMQ 11 Name
SMQ 11 Scope
SMQ 11 Flag
SMQ 12 Name
SMQ 12 Scope
SMQ 12 Flag
SMQ 13 Name
SMQ 13 Scope
SMQ 13 Flag
SMQ 14 Name
SMQ 14 Scope
SMQ 14 Flag
Collected Term for Adverse Reaction
Delayed AR Flag
Analysis Flag 01
Analysis Flag 02
Analysis Flag 03
Analysis Flag 04