This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid. The subject were confined to a clinical after using used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two weeks, the subjects were confined to the clinical for one day. They were required to not use any e-cigarettes for 12 hours prior to the visit. Subjects had to have CO level below a pre-specified level, to attend the visit. IF If the level, was too high, the visit ws was re-scheduled. Subjects were were instructed to take 10 puffs on the e-cigarette. Puff topography was measured using the same device for all subjects.
A Study Reference domain, DI, was used to identify the device used to measure puff topography. The provide a consistent sponsor-defined variable (SPDEVID) for linking data. Device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one device was used for all subjects in the study.
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | 1 | TOPT001 | DI | PUFANYXYZ | 1 | DEVTYPE | Device Type | Puff Topography |
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The sponsor submitted the EX domain to represent the usage of the e-cigarettes. For each subject, the usage for the two weeks are represented, and then the specified usage during the in-clinic visit are shown.
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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1 | TOPT001 | EX | 3001 | 1 | EC-333 | e-nicotine liquid | AD LIBITUM |
| INHALED | 8 | mg/mL | 2020-06-26 | 2020-07-14 | 2 | TENDS01 | EX | 3001 | 2 | EC-333 | e-nicotine liquid | 10 | PUFFS | INHALED | 8 | mg/mL | 2020-07-15T9:00 | 2020-07-15TT9:45 | 3 | TENDS01 | EX | 4001 | 3 | EC-333 | e-nicotine liquid | AD LIBITUM |
| INHALED | 16 | mg/mL | 2020-09-06 | 2020-09-22 | 3 | TENDS01 | EX | 4001 | 4 | EC-333 | e-nicotine liquid | 10 | PUFFS | INHALED | 16 | mg/mL | 2020-09-22T9:00 | 2020-09-22T9:30 |
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The FAEX domain was used to represent the puff topography associated with the in -clinic visit. A puff -by puff analysis was performed. Additionally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session.
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Row 1 | Shows the Number of Puff taken in the interval. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken. | Rows 2-3, 5-6 | Show the puff volume for Subject 3001 for each puff and the puff duration for Subject 4001. FADTC and FAENDTC provides the timing of each puff. Only data for 2 puffs are shown. | Rows 4 & 7 | Shows the mean puff volume for Subject 3001 and the mean puff duration for Subject 4001for all puffs during the interval provided in FADTC and FAENDTC. The NSV variable FACOLSRT indicates that the Mean puff volume is provided. The method to calculate the mean was provided in FAMETHOD, in this situation the DEVICE ALGORITHM. |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | FASEQ | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU | FALOBXFL | FAMETHOD | VISITNUM | FADTC | FAENDTC |
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| FACOLSRT |
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1 | TGI400 | FA | 3001 | PUFANYXYZ | 1 | PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid |
| 10 | PUFFS | 10 | PUFFS |
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| 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 |
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| 1 | TGI400 | FA | 3001 | PUFANYXYZ | 2 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 66.7 | ml/sec | 98 | ml/sec |
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| 2 | 2020-07-15T9:00 |
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| PUFF 1 |
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| 2 | | FA | 3001 | PUFANYXYZ | 3 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 43 | ml/sec | 43 | ml/sec |
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| 2 | 2020-07-15T9:11 |
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| PUFF 2 |
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| 3 | | FA | 3001 | PUFANYXYZ | 4 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 53.7 | ml/sec | 53.7 | ml/sec |
| DEVICE ALGORITHM | 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 |
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| MEAN | 4 | | FA | 4001 | PUFANYXYZ | 1 | PUFFDUR | PUFF DURATION | e-nicotine liquid | PUFF TOPOGRAPHY | 2 | sec | 2 | sec |
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| 2 | 2020-07-22 |
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| PUFF 1 |
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| 5 | | FA | 4001 | PUFANYXYZ | 2 | PUFFDUR | PUFF DURATION | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
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| 2 | 2020-07-22 |
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| PUFF 2 |
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| 6 | | FA | 4001 | PUFANYXYZ | 3 | PUFFDUR | PUFF DURATION | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
| DEVICE ALGORITHM | 2 | 2020-09-22T9:13 | 2020-09-22T9:30 |
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Variable | Label | Type | Role | CODELIST | Origin |
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FACOLSRT | Collected Summary Result Type | text | Non-standard Record Qualifier | (COLSTYP) | CRF |
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