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The demographics (DM) domain is used to represent information about the participants in a clinical study. For more information on this domain, see Section 5.2, Demographics (DM), of the SDTMIG v3.4.

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RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDBRTHDTCAGEAGEUSEXRACEARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1DMD-EFDMDMD-EF-01-1011012021-02-15T09:00






012014-02-078YEARSM
ADrug AADrug A


2DMD-EFDMDMD-EF-01-1021022021-01-13T08:00






012006-05-0114YEARSM
ADrug AADrug A


3DMD-EFDMDMD-EF-01-1031032021-04-15T10:15






012001-07-1019YEARSM
BDrug BBDrug B


4DMD-EFDMDMD-EF-01-1041042021-05-06T09:30






011999-01-1522YEARSM
BDrug BBDrug B


For patients with DMD, it is important to record the height and weight since cardiac index and spirometry results are affected by body surface area (ref: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.115.003810). The vitals signs (VS) dataset contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. For more information on domain see Section 6.3.13, Vital Signs (VS) in the SDTMIG v3.4.

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NameVS
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RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSLOBFXLVISITNUMVISITVSDTC
1DMD-EFVSDMD-EF-01-1011HEIGHTHeight47in119119cm
1VISIT 1
2DMD-EFVSDMD-EF-01-1012WEIGHTWeight20kg2020kg
1VISIT 1
3DMD-EFVSDMD-EF-01-1013HEIGHTHeight52in132132cm
6VISIT 6
4DMD-EFVSDMD-EF-01-1014WEIGHTWeight32kg3232kg
6VISIT 6

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