Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Subject Identifier for the Study (N)
Cohort (N)
Group (N)
Planned Treatment
Planned Treatment (N)
Actual Treatment
Actual Treatment (N)
Sequence Number
Analysis Sequence Number
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Parameter Category 1 (N)
Parameter Category 2
Parameter Category 2 (N)
Vital Signs Position of Subject
Analysis Value
Analysis Value (C)
Clinically Significant
Clinically Significant (N)
Baseline Record Flag
Baseline Value
Baseline Value (C)
Change from Baseline
Percent Change from Baseline
Analysis Reference Range Indicator
Baseline Reference Range Indicator
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Normal/Abnormal/CS
Normal/Abnormal/CS (N)
Analysis Flag 01
Analysis Flag 02
Unscheduled Visit Flag
Post-Baseline Flag
Location of Vital Signs Measurement
Laterality
Date/Time of Measurements
Analysis Date
Analysis Time
Analysis Datetime
Study Day of Vital Signs
Analysis Relative Day
Planned Time Point Name
Planned Time Point Name (N)
Analysis Timepoint
Analysis Timepoint (N)
Time Point Reference
Analysis Timepoint Reference
Date/Time of Reference Time Point
Analysis Visit
Analysis Visit (N)
Visit Name
Visit Number
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)
Cohort Category 1
Cohort Category 1 (N)
Cohort Category 2
Cohort Category 2 (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 Allocation
Time of Allocation
Datetime of Allocation
Source Data
Source Variable
Source Sequence Number