This is an example of an ADMH dataset and is based primarily on input from the SDTM MH dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.
Below This is is an a example of the input SDTM MH datasets used to create the ADMH dataset. Only variables needed for illustration are shown in the examples.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHSPID | MHTERM | MHDECOD | MHCAT | MHBODSYS | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT |
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| 1 | A123 | MH | 2001 | 1 | 01 | ASTHMA | Asthma | GENERAL MEDICAL HISTORY | Respiratory system disorders | 2010 |
| ONGOING | 2021-01-02 | | 2 | A123 | MH | 2001 | 2 | 02 | FREQUENT HEADACHES | Headache | GENERAL MEDICAL HISTORY | Central and peripheral nervous system disorders | 2010-07 |
| ONGOING | 2021-01-02 | | 3 | A123 | MH | 2001 | 3 | 03 | BROKEN LEG | Bone fracture | GENERAL MEDICAL HISTORY | Musculoskeletal system disorders | 2014-07-15 | 2014-08-31 |
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This is an example of the ADMH dataset and associated metadata.
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| Dataset2 |
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| USUBJID | ASTDT | AENDT | ASTDY | AENDY | CMSTDTC | CMENDTC | AOCCFL | AOCCPFL | AOCC01FL | PREFL | ONTRTFL | FUPFL | TRTP | SAFFL | CMTRT | CMDECOD | CMDOSE | CMDOSTXT | CMDOSU | CMCLAS | CMSEQ |
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| ABC123 | ABC12301001 | 01JAN2004 | 01JAN2004 | 1 | 1 | 2004-01-01 | 2004-01-01 | Y | Y | Y |
| Y |
| Product A | Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 1 | | ABC123 | ABC12301001 | 02JAN2004 | 02JAN2004 | 2 | 2 | 2004-01-02 | 2004-01-02 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 2 | | ABC123 | ABC12301001 | 03JAN2004 | 03JAN2004 | 3 | 3 | 2004-01-03 | 2004-01-03 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 3 | | ABC123 | ABC12301001 | 07JAN2004 | 07JAN2004 | 7 | 7 | 2004-01-07 | 2004-01-07 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 4 | | ABC123 | ABC12301001 | 07JAN2004 | 07JAN2004 | 7 | 7 | 2004-01-07 | 2004-01-07 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 5 | | ABC123 | ABC12301001 | 09JAN2004 | 09JAN2004 | 9 | 9 | 2004-01-09 | 2004-01-09 |
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| Y |
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| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 6 | | ABC123 | ABC12301002 |
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| 2004 |
| Y | Y | Y | Y | Y | Y |
| Y | DIOVAN | valsartan | 20 |
| mg | ANTIHYPERTENSIVES | 1 | | ABC123 | ABC12301002 |
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| 2004-01 |
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| Y | Y | Y | Y | Y |
| Y | ZOLOFT | sertraline | 50 |
| mg | PSYCHOANALEPTICS | 2 | | ABC123 | ABC12301002 | 09JAN2004 | 10JUN2004 | 9 | 10 | 2004-01-09 | 2004-06-10 |
| Y | Y |
| Y | Y |
| Y | ASTELIN | azelastine |
| 2 sprays in each nostril-137 mcg | mcg | NASAL PREPARATIONS | 3 | | ABC123 | ABC12301003 | 01JAN2004 |
| 1 |
| 2004-01-01 |
| Y | Y | Y | Y | Y | Y |
| Y | ASPIRIN | acetylsalicylic acid | 100 |
| mg | ANALGESICS | 1 |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADMH |
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| | Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADCM |
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| Analysis |
| ADMH.xpt | ADMH.SAS/SAP | |
| Definexmltable |
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| Dataset | ADMH |
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| Level | Variable |
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| Purpose | Analysis |
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| | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
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| 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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