| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | 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 |
STUDYID | USUBJID | ASTDT | AENDT | AOCCFL | AOCCPFL | AOCCSFL | TRTP | TRTA | SAFFL | RANDFL | TRTSDT | TRTEDT | MHTERM | MHDECOD | MHCAT | MHBODSYS | MHSTDTC | MHENDTC | MHSEQ |
| ABC123 | 123101 | Y | Y | Y | Product A | Product A | Y | Y | ASTHMA | Asthma | GENERAL MEDICAL HISTORY | Respiratory system disorders | 2003 | 1 | |||||
| ABC123 | 123101 | Y | Y | Y | Y | FREQUENT HEADACHES | Headache | GENERAL MEDICAL HISTORY | Central and peripheral nervous system disorders | 2004-07 | 2 | ||||||||
| ABC123 | 123101 | 15JUL2005 | 31AUG2005 | Y | Y | Y | Y | BROKEN LEG | Bone fracture | GENERAL MEDICAL HISTORY | Musculoskeletal system disorders | 2005-07-15 | 2005-08-31 | 3 |
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