| Variable | Label | Type
| Controlled Term
| Role | Comment
|
| USUBJID | Unique Subject Identifier | text | - | Identifier | - |
| AESEQ | Sequence Number | float | - | Selection | - |
| STUDYID | Study Identifier | text | - | Identifier | - |
| DOMAIN | Domain Abbreviation | text | - | Identifier | - |
| SITEID | Study Site Identifier | text | - | Identifier | - |
| SUBJID | Subject Identifier for Study | text | - | Identifier | - |
| AETERM | Reported Term for AE | text | - | Support | - |
| AEDECOD | Dictionary-Derived Term | text | - | Selection | - |
| AEBODSYS | Body System or Organ Class | text | - | Selection | - |
| AESEV | Severity/Intensity | text | SEV | Selection | - |
| AESER | Serious Event | text | YNONLY | Selection | - |
| AESERN | Serious Event, Numeric | float | YN_N | Analysis | - |
| AEREL | Causality | text | AECAUS | Selection | - |
| DSREASAE | Discontinued Due to AE? | text | Y_BLANK | Selection | - |
| ONTRTFL | On or Off Study Treatment Flag | text | YNONLY | Support | - |
| TRTEMFL | Treatment Emergent Flag | text | YNONLY | Selection | - |
| AEFN | 1st AE Occurrence (1= Yes) | float | PRES | Selection | - |
| BODFN | 1st Occurrence of SOC (1 = Yes) | float | PRES | Selection | - |
| DECODFN | 1st Occurrence of PT (1 = Yes) | float | PRES | Selection | - |
| SAEFN | 1st Serious AE Occurrence (1 = Yes) | float | PRES | Selection | - |
| SDECODFN | 1st Serious PT Occurrence (1 = Yes) | float | PRES | Selection | - |
| SBODFN | 1st Serious SOC Occurrence (1 = Yes) | float | PRES | Selection | - |
| AEDERMFN | Special Dermatologic-Related Event (1 = Yes) | float | PRES | Selection | - |
| AESTDT | Start Date/Time of AE | date | - | Support | - |
| AESTDTF | Imputed Date Flag | text | DATEIMP | Support | - |
| AESTDY | Study Day of Start of AE | float | - | Selection | - |
| ANLSTDY | Analysis Start Day | float | - | Timing | - |
| AEENDT | End Date/Time of AE | date | - | Support | - |
| AEENDY | Study Day of End of AE | float | - | Support | - |
| TRTP | !ADaM Description of Planned Arm | text | ARM | Analysis | - |
| TRTPCD | !ADaM Planned Arm Code | text | ARMCD | Analysis | - |
| TRTPN | ADam Planned Arm Code, Numeric | float | ARMCDN | Analysis | - |
| AGE | Age in AGEU at RFSTDTC | float | - | Covariate | AGEU in Years |
| AGEGRP | Age Group | text | AGEGRP | Covariate | - |
| AGEGRPN | Age Group, Numeric | float | AGEGRPN | Covariate | - |
| RACE | Race | text | ADRACE | Covariate | - |
| RACEN | Race, Numeric | float | ADRACEN | Covariate | - |
| SEX | Sex | text | SEX | Covariate | - |
| SAFETY | Safety Population Flag | text | YNONLY | Selection | - |
| ITT | Intent to Treat Population Flag | text | YNONLY | Selection | - |
| EFFICACY | Efficacy Population Flag | text | YNONLY | Selection | - |
| COMPLT24 | Completer of Week 24 Population Flag | text | YNONLY | Selection | - |
| AEDICT | Coding Dictionary Information | text | - | Support | - |
| AESCAN | Involves Cancer | text | YNONLY | Support | - |
| AESCONG | Congenital Anomaly or Birth Defect | text | YNONLY | Support | - |
| AESDISAB | Persist or Significant Disability/Incapacity | text | YNONLY | Support | - |
| AESDTH | Results in Death | text | YNONLY | Support | - |
| AESHOSP | Requires or Prolongs Hospitalization | text | YNONLY | Support | - |
| AESLIFE | Is Life Threatening | text | YNONLY | Support | - |
| HLGTERM | High Level Group Term | text | - | Support | - |
| HLTERM | High Level Term | text | - | Support | - |
| LLTERM | Lower Level Term | text | - | Support | - |
| LSTDOSDT | Date of Last Dose | date | - | Support | - |
| TRTDUR | Duration of Treatment | float | - | Support | In days |
| TRTSTDT | Start Date of Treatment | date | - | Support | - |