This is an example of the ADMH dataset and associated metadata. This is just an example and does not mean to indicate that ADMH must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | Row | STUDYID | USUBJID | MHTERM | MHDECOD | MHBODSYS | ASTDT | AENDT | | AOCCPFL | AOCCSFL | TRTP | TRTA | SAFFL | RANDFL | TRTSDT | TRTEDT | MHCAT | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT | MHSEQ | | 1 | A123 | 2001 | ASTHMA | Asthma | Respiratory system disorders |
|
| Y | Y | Y | Placebo | Placebo | Y | Y |
|
| GENERAL MEDICAL HISTORY | 2003 |
| ONGOING | 2021-01-02 | 1 | | 2 | A123 | 2001 | FREQUENT HEADACHES | Headache | Central and peripheral nervous system disorders |
|
|
| Y | Y | Placebo | Placebo | Y | Y |
|
| GENERAL MEDICAL HISTORY | 2004-07 |
| ONGOING | 2021-01-02 | 2 | | 3 | A123 | 2001 | BROKEN LEG | Bone fracture | Musculoskeletal system disorders | 15JUL2005 | 31AUG2005 |
| Y | Y | Placebo | Placebo | Y | Y |
|
| GENERAL MEDICAL HISTORY | 2005-07-15 | 2005-08-31 |
|
| 3 |
|
|
| Definexmltable |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
| Name | ADMH |
|---|
|
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
| ADMH | Medical History Analysis Dataset | OCCDS | one record per subject per event | Analysis | USUBJID, MHTERM | ADMH.xpt | ADMH.SAS/SAP | |
| Definexmltable |
|---|
| Dataset | ADMH |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| Name | ADMH |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier |
|
...
...
...
| | USUBJID | Unique Subject Identifier |
|
...
...
| 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 |
|
...
...
...
Convert MH.MHSTDTC from character ISO8601 format to numeric date format |
|
...
...
...
| Convert MH.MHENDTC from character ISO8601 format to numeric date format |
|
...
...
| AOCCFL | 1st Occurrence within Subject Flag |
|
...
...
...
| Sort the data in the required order and flag the first |
|
...
| for each subject. | | AOCCPFL | 1st Occurrence of Preferred Term Flag |
|
...
...
| Sort the data in the required order and flag the first |
|
...
| record for each MHDECOD for each subject. | | AOCCSFL | 1st Occurrence of SOC Flag |
|
...
...
| Sort the data in the required order and flag the first |
|
...
| record for each body system for each subject. | | TRTP | Planned |
|
...
...
...
...
...
...
| text | Product A;Product B | Cond | ADSL.TRT01A |
|
| SAFFL | Safety Population Flag |
|
...
...
| ADSL.SAFFL | | RANDFL | Randomized Population Flag |
|
...
| text | Y;N | Cond | ADSL.RANDFL | | TRTSDT | Date of First Exposure to |
|
...
...
| integer |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to |
|
...
...
...
| | MHCAT | Category for Medical History | text |
| Perm | MH.MHCAT | | 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 |
|
...
...