Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
---|
| Study Identifier | text |
| Req | MH.STUDYID |
USUBJID | Unique Subject Identifier | text |
| Req | MH.USUBJID |
MHTERM | Reported Term for the Medical History | text |
| Req | MH.MHTERM |
MHDECOD | Dictionary-Derived Term | text |
| Cond | MH.MHDECOD |
MHBODSYS | Body System or Organ Class | text |
| Cond | MH.MHBODSYS |
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.MHCATMHBODSYS |
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 |
MHENRTPT | End Relative to Reference Time Point | text |
| Perm | MH.MHENRTPT |
MHENTPT | End Reference Time Point | text |
| Perm | MH.MHENTPT |
MHSEQ | Sequence Number | integer |
| Perm | MH.MHSEQ |
| USUBJID | MHTERM | MHDECOD | MHBODSYS | ASTDT | AENDT | | AOCCPFL | AOCCSFL | TRTP | TRTA | SAFFL | RANDFL | TRTSDT | TRTEDT |
MHTERM | MHDECODMHBODSYS | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT | MHSEQ |
ABC123 | 123101 |
A123 | 2001 | ASTHMA | Asthma | Respiratory system disorders |
|
| Y | Y | Y | Product A | Product A | Y | Y |
ASTHMA | Asthma | Respiratory system disorders | 1 | ABC123 | 123101 | Y | Y | Y | Y |
| ONGOING | 2021-01-02 | 1 |
A123 | 2001 | FREQUENT HEADACHES | Headache |
GENERAL MEDICAL HISTORY | Central and peripheral nervous system disorders |
|
|
| Y | Y |
|
| Y | Y |
|
| GENERAL MEDICAL HISTORY | 2004-07 |
| ONGOING | 2021-01-02 | 2 |
|
A123 | 2001 | BROKEN LEG | Bone fracture | Musculoskeletal system disorders |
ABC123 | 123101BROKEN LEG | Bone fractureMusculoskeletal system disorders