Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Planned Treatment
Planned Treatment (N)
Actual Treatment
Actual Treatment (N)
Analysis Date
Analysis Datetime
Analysis Time
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value (C)
Baseline Value
Change from Baseline
Percent Change from Baseline
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Criterion 1 Evaluation Result Flag (N)
Derivation Type
Baseline Record Flag
Lower Limit of Quantitation
Safety Population Flag
Safety Population Flag (N)
Immunogenicity Population Flag
Immunogenicity Population Flag (N)
Reason for Exclusion Immunogenicity Set
Per-Protocol Population Flag
Per-Protocol Population Flag (N)
Reason 1 for Exclusion Per-Protocol Set
Cohort (N)
Cohort Category 1
Cohort Category 1 (N)
Cohort Category 2
Cohort Category 2 (N)
Group (N)
Source Data
Source Variable
Source Sequence Number
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
Sex (N)
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Description of Planned Arm
Description of Actual Arm
Date of Boost Immunization
Datetime of Boost Immunization
Time of Boost Immunization
Date of Prime Immunization
Datetime of Prime Immunization
Time of Prime Immunization