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In this study, the weight of the contents in the cartridges were tracked. A Product Accountability (DA) domain was submitted to represent dispensed and returned weights of the each cartridge each day. Each cartridge had a uniquely assigned number. The sponsor used DAREFID that appeared on the label to identify the cartridgeONly a few rows are shown. The produt accountability information was not provided for the nicotine replaement patches.
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | DASEQ | DAREFID | DATESTCD | DATEST | DACAT | DASCAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | DASTAT | DAREASND | VISITNUM | DADTC |
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| 1 | ABCTEDP07 | DA | ABC-0100110001 | | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.3 | g | 25 | 25 | g | 1 | 2004-06-2606 | | 2 | ABCTEDP07 | DA | ABC-0100110001 | | CRT8768CRT8755 | DISPAMTRETAMT | Dispensed Returned Amount | STUDY PRODUCT | E-LIQUID | 2523 | g | 252325 | 23 | g | 1 | 20042020-06-2606 | | 3 | ABCTEDP07 | DA | ABC-0100110001 | | CRT8769CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.1 | g | 25 | 25 | g | 1 | 20042020-06-2607 | | 4 | ABCTEDP07 | DA | ABC-0100110001 | | CRT8754CRT9757 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | NOT DONE | Subject forgot to return the cartridge | 2020-07-06 | 10 | g | 14 | 143 | 5 | ABC | DA | ABC-01001 | | CRT8768 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 24 | g | 24 | 24 | g | 2 | 2020-07-06 | 6 | ABC | DA | ABC-01001 | | CRT8769 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | -08 | | 5 | TEDP07 | DA | 10001 | | CRT8755 | 10 | g | 10 | 10 | g | 2 | 2020-07-06 | 7 | ABC | DA | ABC-01001 | | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.2 | g | 25 | 25 | g | 2 | 20202004-07-06 | 8 | ABC | DA | ABC-01001 | | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 14 | g | 14 | 143 | g | 3 | 2020-07-10 | 9 | ABC | DA | ABC-01001 | | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 10 | g | 10 | 10 | g | 3 | 2020-07-10 | 10 | ABC | DA | ABC-01001 | | Dispensed Amount | STUDY PRODUCT | PAtCH | 7 | -09 |
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EC was used to represent the collected exposure data since a double dummy design was used. The EX domain was used to represent the subject's exposure to the product containing nicotine.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSU | ECROUTE | ECFREQ | ECLOC | ECLAT | ECDIR | EPOCH | ECSTDTC | ECENDTC |
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| 1 | TEDP07 | EC | 10001 | 1 | ENDS |
| 1PUFF | CONTAINER | INHALEDONCE |
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| TREATMENT | 2020-06-01T8:00 | 2020-06-01T:8:10 |
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| 2 | TEDP07 | EC | 10001 | 2 | PATCH | 1 | PATCH | TRANSDERMAL |
| ARM | RIGHT | UPPER | TREATMENT | 2020-06-01 | 2020-06-02 |
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| 3 | TEDP07 | EC | 10001 | 3 | ENDS | 1 | CONTAINER | INHALED | AD LIBITUM |
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| TREATMENT | 2020-06-01:T12:10 | 2020-06-02 |
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| 4 | TEDP07 | EC | 10001 | 1 | ENDS | 1 | CONTAINER | INHALED | AD LIBITUM |
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| TREATMENT | 2020-06-02 | 2020-06-02 |
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| 5 | TEDP07 | EC | 10001 | 1 | PATCH | 1 | PATCH | TRANSDERMAL |
| ARM | LEFT | UPPER | TREATMENT | 2020-06-02 | 2020-06-03 |
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| 6 | TEDP07 | EC | 10001 | 2 | ENDS | 1 | CONTAINER | INHALED | AD LIBITUM |
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| TREATMENT | 2020-06-03 | 2020-06-03 |
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| 7 | TEDP07 | EC | 10001 | 3 | PATCH | 1 | PATCH | TRANSDERMAL |
| LEG | LEFT | UPPER | TREATMENT | 2020-06-03 | 2020-06-04 |
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| 7 | TEDP07 | EC | 10001 | 4 | ENDS | 1 | CONTAINER | INHALED | AD LIBITUM |
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| TREATMENT | 2020-06-04 | 2020-06-05 |
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| 8 | TEDP07 | EC | 10001 | 5 | PATCH | 1 | PATCH | TRANSDERMAL |
| LEG | LEFT | LOWER | TREATMENT | 2020-06-04 | 2020-06-05 |
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| 9 | TEDP07 | EC | 10001 | 6 | ENDS | 1 | CONTAINER | INHALED | ONCE |
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| TREATMENT | 2020-06-T09;8:30 | 2020-06-T09;8:40 |
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| 10 | TEDP07 | EC | 10001 | 7 | PATCH | 1 | PATCH | TRANSDERMAL |
| LEG | RIGHT | LOWER | TREATMENT | 2020-06-10 | 2020-06-11 |
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| 11 | TEDP07 | EC | 10001 | 8 | ENDS | 1 | CONTAINER | INHALED | AD LIBITUM |
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| TREATMENT | 2020-06-10:T12:40 | 2020-06-11 |
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