Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Subject Identifier for the Study (N)
Cohort (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
Reported Term for the Clinical 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
Category for Clinical Event
Subcategory for Clinical Event
Analysis Category 1
Start Date/Time of Clinical Event
Analysis Start Date
End Date/Time of Clinical Event
Analysis End Date
Analysis Start Relative Day
Study Day of Start of Observation
Analysis End Relative Day
Study Day of End of Observation
Analysis Duration (N)
Analysis Duration Units
Duration
End Relative to Reference Time Point
End Reference Time Point
Analysis Timepoint
Analysis Timepoint (N)
Planned Time Point Name
Analysis Timepoint Reference
Time Point Reference
Clinical Event Occurrence
Clinical Event Pre-Specified
1st Occurrence Local Reaction
1st Occur Gr>=3 Local Reaction
1st Occurrence Local Reaction-Prime
1st Occur Gr>=3 Local Reaction-Prime
1st Occurrence Local Reaction-Boost
1st Occur Gr>=3 Local Reaction-Boost
1st Occurrence Systemic Reaction
1st Occur Gr>=3 Systemic Reaction
1st Occurrence Systemic Reaction-Prime
1st Occur Gr>=3 Systemic Reaction-Prime
1st Occurrence Systemic Reaction-Boost
1st Occur Gr>=3 Systemic Reaction-Boost
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Severity/Intensity
Pooled Severity Group 1
Pooled Severity Group 1 (N)
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
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
Datetime of First Exposure to Treatment
Time of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure to Treatment
Date of Allocation
Time of Allocation
Datetime of Allocation
Date of Prime Immunization
Time of Prime Immunization
Datetime of Prime Immunization
Date of Boost Immunization
Time of Boost Immunization
Datetime of Boost Immunization