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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).
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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 the ones that would be used in a particular study. | |||||||||||||||||||
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STUDYID | USUBJID | MHTERM | MHDECOD | MHBODSYS | ASTDT | AENDT | AOCCFL | AOCCPFL | AOCCSFL | TRTP | TRTA | SAFFL | RANDFL | TRTSDT | TRTEDT | MHCAT | MHSTDTC | MHENDTC | MHSEQ | A123 | 2001 | ASTHMA | Asthma | Respiratory system disorders | Y | Y | Y | Product A | Product A | Y | Y | 08JAN2021 | 28JAN2021 | GENERAL MEDICAL HISTORY | 2003 | 1 | A123 | 2001 | FREQUENT HEADACHES | Headache | Central and peripheral nervous system disorders | Y | Y | Product A | Product A | Y | Y | 08JAN2021 | 28JAN2021 | GENERAL MEDICAL HISTORY | 2004-07 | 2 | A123 | 2001 | BROKEN LEG | Bone fracture | Musculoskeletal system disorders | 15JUL2005 | 31AUG2005 | Y | Y | Product A | Product A | Y | Y | 08JAN2021 | 28JAN2021 | GENERAL MEDICAL HISTORY | 2005-07-15 | 2005-08-31 | 3 |
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| 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
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