Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Investigator Identifier
Stratification Factor 1
Stratification Factor 1 Numeric Code
Stratification Factor 2
Stratification Factor 2 Numeric Code
Sex Numeric Code
Race Numeric Code
Planned Arm Code
Description of Planned Arm
Planned Arm Number
Actually Received Arm Code
Description of Actually Received Arm
Actually Received Arm Number
Randomized Population
Safety Population
Completers Population
Exposed Population
Intent-to-treat Population
Subject Reference Start Date
Subject Reference Start Date (Char)
Subject Reference End Date
Subject Reference End Date (Char)
Treatment End Date/Time
Treatment End Date
Treatment End Date (Char)
Domain Abbreviation
Sequence Number
Reference ID
Sponsor-Defined Identifier
Reported Term for the Adverse Event
Modified Reported Term
Dictionary-Derived Term
Category for Adverse Event
Body System or Organ Class
System Organ Class Code
BODSYS Primary SOC Flag
Preferred Term Code
Lowest Level Term
Lowest Level Term Code
LLT Current
High Level Group Term
High Level Group Term Code
High Level Term
High Level Term Code
Body System or Organ Class MedDRA Order
Preferred Term Order
Dictionary Version
Severity/Intensity
Severity/Intensity Numeric Code
Serious Event
Action Taken with Study Treatment
Action Taken with Study Treatmt Derived
Causality to Injection
Causality to Capsule
Pattern of Adverse Event
Outcome of Adverse Event
Outcome of Adverse Event Numeric Code
Specify Sequelae
Occurred with Pregnancy
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
Occurred with Overdose
Concomitant or Additional Trtmnt Given
AE Duplication Sequence Number
AE Update Period
Start Date/Time of Adverse Event
Start Date of Adverse Event
Start Date of Adverse Event (Char)
Start Date of Adverse Event Flag
Start Time of Adverse Event
Start Time of Adverse Event (Char)
End Date/Time of Adverse Event
End Date of Adverse Event
End Date of Adverse Event (Char)
End Time of Adverse Event
End Time of Adverse Event (Char)
Study Day of Start of Adverse Event
Study Day of End of Adverse Event
Duration of Adverse Event
Duration of Adverse Event Units
Duration of Adverse Event (Char)
Date/Time of Death
Date of Death
Date of Death (Char)
Time of Death
Time of Death (Char)
Study Day of Death
Treatment Emergent Classification
Treatment Emergent Classification Flag
Injection Site Reaction Flag