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Xformpusher |
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Order | CDASH Variable | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
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1 | CMYNCMOCCUR | Were any smoking cessation products taken? | Any Smoking Cessation Products | Indicate if the subject took any smoking cessation products If Yes, include the appropriate details where indicated on the CRF. | Text | N/A | CMOCCUR | (NY) | Yes; No |
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For each product previously taken record the appropriate details below.
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Row 1: | Show Shows the subject reported they had not previously used any smoking cessation product. | Row 2: | Shows the subject reported using Nicotine Gum. This gum was used within 14 days of the date of collection. Since, the last date of use is not known CMENDTC describe the beginning and the end of the interval of uncertainty. The dates are separate them with a solidus, as shown in the following table. | Row 3: | Shows Shows subject reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15. This usage was ended at least 14 days prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case 2020-02-12. CMENRTPT indicates the usage ended prior to the date in CMENTPT. | Rows 4-6: | Shows Show the subject used these products . The subject discontinued Zyban for an adverse event. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMOCCOR | CMPRESP | CMRSDISC | CMDTC | CMENDTC | CMENTPT | CMENRTPT |
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1 | ABC | CM | XYZ-0001 | 1 | SMOKING CESSATION PRODUCT |
| N |
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| 2020-01-05 |
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| 2 | ABC | CM | ABC-0001 | 3 | NICOTINE GUM | SMOKING CESSATION PRODUCT |
| Y |
| 2020-02-15 | 2020-02-02/2003-02-15 |
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| 3 | ABC | CM | ABC-0001 | 4 | NICOTINE LOZENGE | SMOKING CESSATION PRODUCT |
| Y |
| 2020-02-15 |
| 2020-02-12 | PRIOR | 4 | ABC | CM | ABC-0003 | 1 | NICOTINE INHALER | SMOKING CESSATION PRODUCT |
| Y |
| 2021-04-16 | 2004-01-07 |
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| 5 | ABC | CM | ABC-0003 | 2 | Chantix | SMOKING CESSATION PRODUCT |
| Y |
| 2021-04-16 | 2004-01-07 |
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| 6 | ABC | CM | ABC-0003 | 3 | Zyban | SMOKING CESSATION PRODUCT |
| Y | CMRSDISC | 2021-04-16 | 2004-01-09 |
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