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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | DASEQ | SPTOBID | DAREFID | DATESTCD | DATEST | DACAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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| 1 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 2 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8768 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 3 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8769 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 4 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | 2 | mL | 2 | 2 | mL | 2 | 2020-07-06 | | 2 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8768 | RETAMT | Returned Amount | STUDY PRODUCT | 1.6 | mL | 1.6 | 1.6 | mL | 2 | 2020-07-06 | | 3 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8769 | RETAMT | Returned Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 5 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 6 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | 1.0 | mL | 1.0 | 1.0 | mL | 3 | 2020-07-10 |
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Since the data in Exposure as collected Collected (EC) would be practically identical to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.
The sponsor used the an electronic diary to determine collect the start and end date of the insertion and removal date of each cartridge in the ENDS device. For simplicity, in this example, the actual times of insertion/removal were not usedcollected, but may often be collected.
The domain represented the total amount of liquid product used from each cartridge which was determined from using the data in the DA domain. The associated nicotine pharmaceutical strength of each cartridge was known. The sponsored used this information in the analysis. The summaries included in the analysis were the estimated number of cartridges used per week, and the estimated nicotine exposure from the cartridges per day.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID | EXREFID | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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| 1 | TENDS01 | EX | TEN01001 | 1 | VAPE-Z27 | CRT8754 | e-nicotine liquid | 6 | mL | CARTRIDGE | INHALED | 8 | mg/mL | 2020-06-26 | 2020-07-01 | | 2 | TENDS01 | EX | TEN01001 | 2 | VAPE-Z27 | CRT8768 | e-nicotine liquid | 6.4 | mL | CARTRIDGE | INHALED | 8 | mg/mL | 2020-07-01 | 2020-07-06 | | 3 | TENDS01 | EX | TEN01001 | 3 | VAPE-Z27 | CRT9756 | e-nicotine liquid | 7 | mL | CARTRIDGE | INHALED | 8 | mg/mL | 2020-07-06 | 2020-07-10 | | 3 | TENDS01 | EX | TEN01001 | 4 | VAPE-Z27 | CRT9778 | e-nicotine liquid | 8 | mL | CARTRIDGE | INHALED | 8 | mg/mL | 2020-07-10 | 2020-07-14 | | 4 | TENDS01 | EX | TEN10002 | 1 | VAPE-Z27 | CRT8000 | e-nicotine liquid | 5 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EX | TEN10002 | 2 | VAPE-Z27 | CRT9006 | e-nicotine liquid | 7 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EX | TEN10002 | 3 | VAPE-Z27 | CRT9008 | e-nicotine liquid | 8 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EX | TEN10002 | 4 | VAPE-Z27 | CRT9017 | e-nicotine liquid | 6 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EX | TEN10002 | 5 | VAPE-Z27 | CRT9089 | e-nicotine liquid | 7 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EX | TEN10002 | 6 | VAPE-Z27 | CRT9128 | e-nicotine liquid | 8 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EX | TEN10002 | 7 | VAPE-Z27 | CRT6868 | e-nicotine liquid | 6.7 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EX | TEN10002 | 8 | VAPE-Z27 | CRT7868 | e-nicotine liquid | 5.5 | mL | CARTRIDGE | INHALED | 0 | mg/mL | 2020-10-15 | 2020-10-22 |
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