The ADMH dataset is based primarily on input from the SDTM MH dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).
Example
This is an example of an input SDTM MH datasets used to create the example ADMH dataset. Only variables needed for illustration are shown in the examples.
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.
ADMH Dataset Metadata
| 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 |
ADMH Variable Metadata
| 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 | |
| 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 Product | text | Product A;Product B | Cond | ADSL.TRT01P |
| TRTA | Actual Product | 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 Product | integer | Perm | ADSL.TRTSDT | |
| TRTEDT | Date of Last Exposure to Product | integer | Perm | ADSL.TRTEDT | |
| 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 | |
| MHSEQ | Sequence Number | integer | Perm | MH.MHSEQ |
Overview
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