| CDASH Variable Name | CRF | Case Report Form Completion Instructions | Type |
|---|
SDTMIG Target SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 1 |
CMTRT | medication | medically recognized product name? | Medication |
| Text | CMTRTC |
CMCATNICOTINE REPLACEMENT THERAPY; IN REDUCING OTHER THAN NRTS; CMPRESP |
| Pre-Specified Intervention |
| Text | CMPRESP |
CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATIONCMOCCUR | | Did the subject previously use |
medications | medically recognized products to reduce nicotine dependency? | Any |
Medications | Medically Rrecognized Products Taken For Nicotine Dependency | Indicate if the subject had used any medically |
acceptable | recognized products to attempt to |
reduce nicotine dependency| reduce nicotine dependency | Text | CMOCCUR | CMOCCUR |
| (NY) | No;Yes;Not Done |
| | 4 |
CMTRT | 4 | FAORRES | How many times did the subject attempt to use |
a medicaiton | use medically recognized products to reduce nicotine dependency | Times the Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempted to use |
a medicaiton | medically recognized products to reduce nicotine dependency |
CMDUR | Text | FAORRES | FAORRES | FAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number " |
|
|
| | 5 |
| Category |
| Text | FACAT |
| FACAT |
|
|
| ATTEMPTS TO REDUCE NICOTINE DEPENDENCE |
| What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | CMDUR | DAYS; MONTHS; YEARS | 6 | CMCAT | | Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 6 |
the | the medication/product the subject used to attempt to reduce nicotine dependency? |
Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | CMCAT |
|
| NICOTINE REPLACEMENT THERAPY |
; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; 7 | CMSCAT the subcategory for ?Medication Subcategory | Record the medication | /product subcategory, if not pre-printed on the CRF. | Subcategory | Applicant Defined | Text | CMSCAT | CMSCAT |
|
| LAST ATTEMPTED USE WITH THIS MEDICATION |
| | 8 |
CMTRT | What was the name of the medication/product the subject used to reduce nicotine dependency?
| Medication | Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name. | Text | CMTRT | CMTRT |
|
|
|
| | 9 |
CMCDUR | | What was the duration of the medication/product used to reduce nicotine dependency for the last attempt? |
| Collected Duration | Provide the duration of the medication/product used. | Text | CMCDUR | CMDUR |
|
|
|
| | 10 |
CMCDURU | What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt? |
| Collected Duration Unit | Select the appropriate duration unit of the medication/product used. |
| Text | CMCDURU | CMDUR |
| (UNIT) | DAYS; MONTHS; YEARS |
|
| 
