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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Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | DTHDTC | DTHFL | SITEID | BRTHDTC | AGE | AGEU | SEX | RACE | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
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1 | DMD-EF | DM | DMD-EF-01-101 | 101 | 2021-02-15T09:00 |
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| 01 | 2014-02-07 | 8 | YEARS | M |
| A | Drug A | A | Drug A |
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| 2 | DMD-EF | DM | DMD-EF-01-102 | 102 | 2021-01-13T08:00 |
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| 01 | 2006-05-01 | 14 | YEARS | M |
| A | Drug A | A | Drug A |
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| 3 | DMD-EF | DM | DMD-EF-01-103 | 103 | 2021-04-15T10:15 |
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| 01 | 2001-07-10 | 19 | YEARS | M |
| B | Drug B | B | Drug B |
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| 4 | DMD-EF | DM | DMD-EF-01-104 | 104 | 2021-05-06T09:30 |
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| 01 | 1999-01-15 | 22 | YEARS | M |
| B | Drug B | B | Drug B |
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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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Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOBFXL | VISITNUM | VISIT | VSDTC |
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1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | 47 | in | 119 | 119 | cm |
| 1 | VISIT 1 |
| 2 | DMD-EF | VS | DMD-EF-01-101 | 2 | WEIGHT | Weight | 20 | kg | 20 | 20 | kg |
| 1 | VISIT 1 |
| 3 | DMD-EF | VS | DMD-EF-01-101 | 3 | HEIGHT | Height | 52 | in | 132 | 132 | cm |
| 6 | VISIT 6 |
| 4 | DMD-EF | VS | DMD-EF-01-101 | 4 | WEIGHT | Weight | 32 | kg | 32 | 32 | kg |
| 6 | VISIT 6 |
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