This is the SDTM date for the date data collected above. In this example, the sponsor applicant only represented whether the product was used in the last 14 days. CMPRESP was populated by the sponsor applicant for all pre-specified treatmentsproducts. Medication specified as "OTHER" : were not considered pre-specifedprespecified.
| Dataset wrap |
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| Rowcaps |
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| 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. |
| 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. CMPRESP is used to repesent that this product was pre-specified. CMOCCUR is null, since the sponsor did not directly ask on the CRF whether the 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 asked. | | Rows 2, 5, 8, 11, 14, 17: | Show the subject reported they had used a smoking cessation product (CMOCCUR ="Y") . CMPRESP was included to indicate that the use of a smoking cessation product was specifically asked on the CRF. | | Rows 3, 6, 9, 12, 15, 18: | Show the subject reported they had not used nicotine patches (CMOCCUR is "N"). Note: that all other rows for the products not used are not show for simplicity CMPRESP is used to represent that this product was pre-specified. | | Rows 4, 7, 10, 13, 16: | Shows the subject reported using the product specified in CMTRT. CMENDTC indicates the last day the product was used. CMPRESP is used to represent that this product was pre-specified. CMOCCUR is Y. |
Rows 7,9,11: | Show the subjects used the product shown in CMTRT. | Subject ABC-0006 discontinued BUPROPION for an adverse event. |
13| 19: | Shows the subject used |
a Natural Supplement | natural supplement ABC for smoking cessation. Since |
, specifed | specified on the CRF, CMPRESP is null. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMCAT | CMPRESP | CMOCCUR | CMRSDISC | CMDTC | CMENDTCCMENRTPT | 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 GUMPAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-02-15 |
| | 4 | ABC | CM | ABC-0002 | 3 | NICOTINE GUM | SMOKING CESSATION PRODUCT | Y | Y |
| 2020-02-15 | 2020-02/2003-02-15 | | 45 | ABC | CM | ABC-0003 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-04-15 |
| | 56 | ABC | CM | ABC-0003 | 2 | NICOTINE LOZENGEPAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-04-15 |
| | 7 | ABC | CM | ABC-0003 | 3 | NICOTINE LOZENGE | SMOKING CESSATION PRODUCT | Y | YPRIOR |
| 2020-04-0215 | 2012 | | 68 | ABC | CM | ABC-0004 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
| | 79 | ABC | CM | ABC-0004 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-04-16 |
| | 10 | ABC | CM | ABC-0004 | 3 | NICOTINE INHALER | SMOKING CESSATION PRODUCT | Y | Y |
| 2021-04-16 | 2021-01-07 | | 811 | ABC | CM | ABC-0005 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-09-24 |
| | 912 | ABC | CM | ABC-0005 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-09-24 |
| | 13 | ABC | CM | ABC-0005 | 3 | VARENICLINE | SMOKING CESSATION PRODUCT | Y | Y |
| 2020-09-24 | 2020-08-07 | | 1014 | ABC | CM | ABC-0006 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2021-04-16 |
| | 15 | ABC | CM | ABC-0002 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2021-04-16 |
| | 1611 | ABC | CM | ABC-0006 | 23 | BUPROPION | SMOKING CESSATION PRODUCT | Y | Y | ADVERSE EVENT | 2021-04-16 | 2020-01-09 | | 1217 | ABC | CM | ABC-0007 | 1 | SMOKING CESSATION PRODUCT |
| Y | Y |
| 2020-07-10 |
| | 18 | ABC | CM | ABC-0002 | 2 | NICOTINE PAtCH | SMOKING CESSATION PRODUCT | Y | N |
| 2020-07-10 |
| | 1913 | ABC | CM | ABC-0007 | 2 | NATURAL SUPPLEMENT ABC | SMOKING CESSATION PRODUCT |
| Y |
| 2020-07-10 | 2020-04-10 |
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