Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Subject Identifier for the Study (N)
Cohort (N)
Pooled Age Group 1
Pooled Age Group 1 (N)
Cohort Category 1
Cohort Category 1 (N)
Cohort Category 2
Cohort Category 2 (N)
Group (N)
Planned Treatment
Planned Treatment (N)
Actual Treatment
Actual Treatment (N)
Sequence Number
Group ID
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Modified Reported Term
Lowest Level Term
Lowest Level Term Code
Dictionary-Derived Term
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Category for Adverse Event
Body System or Organ Class
Body System or Organ Class Code
Primary System Organ Class
Primary System Organ Class Code
Severity/Intensity
Standard Toxicity Grade
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Serious Event
Serious Event (N)
Action Taken with Study Treatment
Analysis Action Taken with Study Trtmnt
Analysis Action Taken with Trtmnt (N)
Causality
Analysis Causality
Analysis Causality (N)
Outcome of Adverse Event
Analysis Outcome of Adverse Event
Analysis Outcome of Adverse Event (N)
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
Concomitant or Additional Trtmnt Given
Treatment Emergent Flag
Dose limiting Toxicity
Epi/Pandemic Related Indicator
Treatment emergent related AE
Treatment emergent severe AE
Treatment emergent severe related AE
Serious treatment emergent AE
Serious treatment emergent related AE
Preferred Term based on diary entry
Start Date/Time of Adverse Event
Analysis Start Date
Analysis Start Time
Analysis Start Date/Time
End Date/Time of Adverse Event
Analysis End Date
Analysis End Time
Analysis End Date/Time
Study Day of Start of Adverse Event
Analysis Start Relative Day
Study Day of End of Adverse Event
Analysis End Relative Day
Analysis Duration (N)
Analysis Duration Units
Days since last dose
End Relative to Reference Time Point
End Reference Time Point
Treatment Emergent Analysis Flag
Time Interval 1 Flag
Time Interval 2 Flag
Time Interval 3 Flag
Time Interval 4 Flag
Time Interval 5 Flag
Age Units
Sex (N)
Race (N)
Screened Population Flag
Screened Population Flag (N)
Safety Population Flag
Safety Population Flag (N)
Safety Boost Population Flag
Safety Boost Population Flag (N)
Immunogenicity Population Flag
Immunogenicity Population Flag (N)
Per-Protocol Population Flag
Per-Protocol Population Flag (N)
Prime + 7 Days Completers Set
Prime + 7 Days Completers Set (N)
Prime to Boost or Prime +28 D. Comp. Set
Pri. to Bo. or Pri. +28 D. Comp. Set (N)
Boost + 7 Days Completers Set
Boost + 7 Days Completers Set (N)
Boost + 28 Days Completers Set
Boost + 28 Days Completers Set (N)
Prime or Boost + 28 Days Completers Set
Prime or Boost + 28 Days Comp. Set (N)
Completers Population Flag
Completers Population Flag (N)
Date of First Exposure to Treatment
Time of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Time of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of Prime Immunization
Time of Prime Immunization
Datetime of Prime Immunization
Date of Boost Immunization
Time of Boost Immunization
Datetime of Boost Immunization
Date of Allocation
Time of Allocation
Datetime of Allocation