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 3.3.6.1, Subject-level Analysis Dataset (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.

mh.xpt

mh.xpt

RowSTUDYIDDOMAINUSUBJIDMHSEQMHSPIDMHTERMMHDECODMHCATMHBODSYSMHSTDTCMHENDTCMHENRTPTMHENTPT
1A123MHA2001101ASTHMAAsthmaGENERAL MEDICAL HISTORYRespiratory system disorders2010
ONGOING2021-01-02
2A123MHA2001202FREQUENT HEADACHESHeadacheGENERAL MEDICAL HISTORYCentral and peripheral nervous system disorders2010-07
ONGOING2021-01-02
3A123MHA2001303BROKEN LEGBone fractureGENERAL MEDICAL HISTORYMusculoskeletal system disorders2014-07-152014-08-31

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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.   

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admh.xpt

RowSTUDYIDUSUBJIDMHTERMMHDECODMHBODSYSASTDTAENDT

AOCCFL

AOCCPFLAOCCSFLTRTPTRTASAFFLRANDFLTRTSDTTRTEDTMHCATMHSTDTCMHENDTCMHENRTPTMHENTPTMHSEQ
1A1232001ASTHMAAsthmaRespiratory system disorders

YYYPlaceboPlaceboYY

GENERAL MEDICAL HISTORY2003
ONGOING2021-01-021
2A1232001FREQUENT HEADACHESHeadacheCentral and peripheral nervous system disorders


YYPlaceboPlaceboYY

GENERAL MEDICAL HISTORY2004-07
ONGOING2021-01-022
3A1232001BROKEN LEGBone fractureMusculoskeletal system disorders15JUL200531AUG2005
YYPlaceboPlaceboYY

GENERAL MEDICAL HISTORY2005-07-152005-08-31

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ADMH Dataset Metadata

DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADMHMedical History Analysis DatasetOCCDSone record per subject per eventAnalysisUSUBJID, MHTERMADMH.xptADMH.SAS/SAP

ADMH Variable Metadata

Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study Identifiertext
ReqMH.STUDYID
USUBJIDUnique Subject Identifiertext
ReqMH.USUBJID
MHTERMReported Term for the Medical Historytext
ReqMH.MHTERM
MHDECODDictionary-Derived Termtext
CondMH.MHDECOD
MHBODSYSBody System or Organ Classtext
CondMH.MHBODSYS
ASTDTAnalysis Start Dateinteger
Cond

Convert MH.MHSTDTC from character ISO8601 format to numeric date format

AENDTAnalysis End Dateinteger
CondConvert MH.MHENDTC from character ISO8601 format to numeric date format
AOCCFL1st Occurrence within Subject FlagtextYPermSort the data in the required order and flag the first for each subject.
AOCCPFL1st Occurrence of Preferred Term FlagtextYPermSort the data in the required order and flag the first record for each MHDECOD for each subject.
AOCCSFL1st Occurrence of SOC FlagtextYPermSort the data in the required order and flag the first record for each body system for each subject.
TRTPPlanned ProducttextProduct A;Product BCondADSL.TRT01P
TRTAActual ProducttextProduct A;Product BCondADSL.TRT01A
SAFFLSafety Population FlagtextY;NCondADSL.SAFFL
RANDFLRandomized Population FlagtextY;NCondADSL.RANDFL
TRTSDTDate of First Exposure to Productinteger
PermADSL.TRTSDT
TRTEDTDate of Last Exposure to Productinteger
PermADSL.TRTEDT
MHCATCategory for Medical Historytext
PermMH.MHCAT
MHSTDTCStart Date/Time of Medical History Eventtext
PermMH.MHSTDTC
MHENDTCEnd Date/Time of Medical History Eventtext
PermMH.MHENDTC
MHENRTPTEnd Relative to Reference Time Pointtext
PermMH.MHENRTPT
MHENTPTEnd Reference Time Pointtext
PermMH.MHENTPT
MHSEQSequence Numberinteger
PermMH.MHSEQ

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