| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier | text |
| Req | MH.STUDYID |
| USUBJID | Unique Subject Identifier | text |
| Req | MH.USUBJID |
| ASTDT | Analysis Start Date | integer |
| Cond | Convert MH.MHSTDTC from character ISO8601 format to numeric date format |
| AENDT | Analysis End Date | integer |
| Cond | Convert MH.MHENDTC from character ISO8601 format to numeric date format |
| AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | Sort the data in the required order and flag the first for each subject. |
| AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | Sort the data in the required order and flag the first record for each MHDECOD for each subject. |
| AOCCSFL | 1st Occurrence of SOC Flag | text | Y | Perm | Sort the data in the required order and flag the first record for each body system for each subject. |
| TRTP | Planned Treatment | text | Product A;Product B | Cond | ADSL.TRT01P |
| TRTA | Actual Treatment | text | Product A;Product B | Cond | ADSL.TRT01A |
| SAFFL | Safety Population Flag | text | Y;N | Cond | ADSL.SAFFL |
| RANDFL | Randomized Population Flag | text | Y;N | Cond | ADSL.RANDFL |
| TRTSDT | Date of First Exposure to Treatment | integer |
| Perm | ADSL.TRTSDT |
| TRTEDT | Date of Last Exposure to Treatment | integer |
| Perm | ADSL.TRTEDT |
| MHTERM | Reported Term for the Medical History | text |
| Req | MH.MHTERM |
| MHDECOD | Dictionary-Derived Term | text |
| Cond | MH.MHDECOD |
| MHCAT | Category for Medical History | text |
| Perm | MH.MHCAT |
| MHBODSYS | Body System or Organ Class | text |
| Cond | MH.MHBODSYS |
| MHSTDTC | Start Date/Time of Medical History Event | text |
| Perm | MH.MHSTDTC |
| MHENDTC | End Date/Time of Medical History Event | text |
| Perm | MH.MHENDTC |
| MHSEQ | Sequence Number | integer |
| Perm | MH.MHSEQ |