| Rowcaps |
|---|
| Row 1: | Shows the subject reported they had not previously used any smoking cessation product (e.g., CMOCCUR ="N") . CMPRESP was included to indicate that the use of smoking cessation product was specifically asked on the CRF. | | Rows 2, 4, 6, 8, 10, 12: | Show the subjects reported they had previously used smoking cessation products (e.g., CMOCCUR ="Y"). CMPRESP was included to indicate that the use of smoking cessation product was specifically asked. | | Row 3: | 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 described the beginning and the end of the interval of uncertainty. The dates are separated with a solidus, as shown in the table CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is null, since the applicant did not directly ask on the CRF whether the this specific product was taken. The investigator just checked which products were used. | | Row 5: | Shows the 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 2020-04-01. CMENRTPT indicated the usage ended prior to the date in CMENTPT. | Rows 2, 4, 6, 8, 10, 12: | Show the subjects reported they had previously used smoking cessation products (e.g., CMOCCUR =N). CMPRESP was included to indicate that the use of smoking cessation product was specifically askedwith a last know date of use of 2012. | | Rows 7, 9, 11: | Show the subjects used the product shown in CMTRT. Subject ABC-0006 discontinued BUPROPION for an adverse event. | | Row 13: | Shows the subject used a Natural Supplement ABC for smoking cessation. Since, this product was not specified on the CRF, CMPRESP is null. |
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| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMPRESP | CMOCCUR | CMRSDISC | CMDTC | CMENDTC | CMENRTPT | CMENTPT |
|---|
| 1 | ABC | CM | ABC-0001 | 1 | SMOKING CESSATION PRODUCT |
| Y | N |
| 2020-01-05 |
| | 2 | ABC | CM | ABC-0002 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-0102-0515 |
| | 3 | ABC | CM | ABC-0002 | 2 | NICOTINE GUM | SMOKING CESSATION PRODUCT | Y |
|
| 2020-02-15 | 2020-02-02/2003-02-15 | | 4 | ABC | CM | ABC-0003 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-04-15 |
| | 5 | ABC | CM | ABC-0003 | 2 | NICOTINE LOZENGE | SMOKING CESSATION PRODUCT | Y |
|
| 2020-04-15 | PRIOR | 2020-04-022012 | | 6 | ABC | CM | ABC-0004 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
| | 7 | ABC | CM | ABC-0004 | 2 | NICOTINE INHALER | SMOKING CESSATION PRODUCT | Y |
|
| 2021-04-16 | 2021-01-07 | | 8 | ABC | CM | ABC-0005 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-09-24 |
| | 9 | ABC | CM | ABC-0005 | 2 | VARENICLINE | SMOKING CESSATION PRODUCT | Y |
|
| 2020-09-24 | 2020-08-07 | | 10 | ABC | CM | ABC-0006 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
| | 11 | ABC | CM | ABC-0006 | 2 | BUPROPION | SMOKING CESSATION PRODUCTY |
|
| ADVERSE EVENT | 2021-04-16 | 2020-01-09 | | 12 | ABC | CM | ABC-0007 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-07-10 |
| | 13 | ABC | CM | ABC-0007 | 2 | NATURAL SUPPLEMENT ABC | SMOKING CESSATION PRODUCT |
|
|
| 2020-07-10 | 2020-04-10 |
|
|