This example shows data about concomitant medications collected during a study.
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is the SDTM dataset associated with the above example CRF. This SDTM dataset used CMENRF to represent ongoing interventions. More information can be found in Section 2.8.7.6, Representing References and Relative Timing.
The applicant included CMDECOD. The applicant is required to provide the dictionary name and version in the Define-XML document.
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This is the SDTM dataset associated with the above example CRF.
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| Rowcaps |
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| Rows 1-64: | The subject reported each instance of aspirin use. The frequency in of each record instance is (represented in CMDOSFRQ ) and is " ONCE". | | Rows 76-98: | The subject reports the use of 3 medications. Diovan and Zoloft were still being taken by the subject, Astelin was a a nasal spray where 2 sprays were taken twice be a day in each nostril. Note that only partial start dates are provided for Diovan and Zoloft. | | Row 109: | The subject took aspirin with a frequency of "PRN". This approach assumes that knowing exactly when aspirin was used is not important for evaluating safety and efficacy the product in this study. | |
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMDECOD | CMINDC | CMCLAS | CMDOSE | CMDOSTXT | CMDOSU | CMDOSFRM | CMDOSFRQ | CMROUTE | CMSTDTC | CMENDTC | CMENRF |
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| 1 |
ABCABC| ABC123-0001 | 1 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010120040101ABCABC| ABC123-0001 | 2 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010220040102ABCABC| ABC123-0001 | 3 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010320040103ABCABC| ABC123-0001 | 4 | ASPIRIN | acetylsalicylic acid | MIGRAINE | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004010720040107ABCABC100mgTABLET | ONCE | ORAL | 2004-01-07 | 2004-01-07 | 6 | ABC | CM | ABC-0001 | 6 | ASPIRIN | | ANALGESICS | 100 |
| mg | TABLET | ONCE | ORAL |
2004092004097ABCABC| ABC123-0002 | 1 | DIOVAN | valsartan | HYPERTENSION | ANTIHYPERTENSIVES | 20 |
| mg | TABLET | BID | ORAL | 2004 |
-01-01ONGOING8ABCABC| ABC123-0002 | 2 | ZOLOFT | sertraline | PANIC ATTACKS | PSYCHOANALEPTICS | 50 |
| mg | TABLET | OD | ORAL | 2004-01 |
-07ONGOING9ABCABC| ABC123-0002 | 3 | ASTELIN | azelastine | INFLUENZA | NASAL PREPARATIONS |
| 2 sprays in each nostril-137 |
mcg 200401092004-06-10 | 10 | ABCABC00031| 4 | ASPIRIN | acetylsalicylic acid | PAIN | ANALGESICS | 100 |
| mg | TABLET | PRN | ORAL | 2004-01-01 |
2004-01-09 |
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