| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | CMCAT | What is the category of the medication the subject used to attempt to reduce nicotine dependency? for the medication? | Concomitant Medication Category |
| CMCAT |
|
|
| SMOKING CESSATION PRODUCT |
| 2 | CMOCCUR | Were any smoking cessation products taken? | Any Smoking Cessation Products Taken | Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | Indicate if the subject experienced any medical conditions or events. took any smoking cessation products If Yes, include the appropriate details where indicated on the CRF. | CMCATCMOCCUR NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; | 2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | CMOCCUR;CMPRESP | (NY) | Yes; No |
|
| 3 | CMTRT | What was the smoking cessation product used? | Smoking Cessation Product | Select the smoking cessation product. | CMTRT | CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL. |
| NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER |
|
| 4 | CMOCCUR | Was the smoking cessation product used? | Smoking Cessation Product Used | For each product indicate if the product was used. | CMOCCUR | CMOCCUR |
| Yes;No |
|
| 5 | CMTRTOT | What was the name of the other smoking cessation product used? | Smoking Cessation Product Other | Indicate the Other type of product previously used. | CMTRT |
|
|
|
|
| 6 | CMCRSDIS | Was the smoking cessation product discontinued due to a adverse experience? | Reason Smoking Cessation Product Discontinued | Indicate if the product was discontinued due to a Adverse Experience | CMRSDISC | If Yes then CMRSDISC = "ADVERSE Experience" | (NY) | Yes; No |
|
| 7 | CMENDAT | What was the last date the product was used? | Last Date Smoking Cessation Product Used | Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise partial dates can be recorded. | CMENDTC | LAST ATTEMPTED USE WITH THIS MEDICATION | 3 | What was the name of the medication the subject used to reduce nicotine dependency?
Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | Applicant-Defined CRF Completion Instructions | CMTRT | 4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | CMDUR | 5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | CMDUR | DAYS; MONTHS; YEARS |
|
|
|
|