This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid. The subject 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 the level, was too high, the visit was re-scheduled. Subjects were instructed to take 10 puffs on the e-cigarette in the morning and afternoon. Puff topography was measured in the morning and afternoon using the same device for all subjects. Subjects were not allowed to use any tobacco products between the morning and afternoon sessions.
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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Dataset2 |
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | 1 | TOPT001 | DI | PUFANYXYZ | 1 | DEVTYPE | Device Type | PUFF TOPOGRAPHER | 2 | TOPT001 | DI | PUFANYXYZ | 2 | MODEL | Model | PUFFALYZER 900 | 3 | TOPT001 | DI | PUFANYXYZ | 3 | MANUF | Manufacturer | ACME |
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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. The sponsor elected not to represent each puff in this EX dataset. Each Puff could have been recorded.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID | EXLNKID | 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 | 1 | e-nicotine liquid | 10 | PUFFS | INHALED | 8 | mg/mL | 2020-07-15T9:00 | 2020-07-15TT9:45 | 3 | TENDS01 | EX | 3001 | 3 | EC-333 | 2 | e-nicotine liquid | 10 | PUFFS | INHALED | 8 | mg/mL | 2020-07-15T3:00 | 2020-07-15TT3:45 | 4 | TENDS01 | EX | 4001 | 1 | EC-333 |
| e-nicotine liquid | AD LIBITUM |
| INHALED | 16 | mg/mL | 2020-09-06 | 2020-09-22 | 5 | TENDS01 | EX | 4001 | 2 | EC-333 | 1 | e-nicotine liquid | 10 | PUFFS | INHALED | 16 | mg/mL | 2020-09-22T9:00 | 2020-09-22T9:30 | 6 | TENDS01 | EX | 4001 | 3 | EC-333 | 2 | e-nicotine liquid | 10 | PUFFS | INHALED | 16 | mg/mL | 2020-09-22T3:00 | 2020-09-22T3:30 |
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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. FATPT was used to represent the time point, in this case, AM and PM. Additonally , the vendor provided the mean of the measurements of 10 puffs in the mornings, and also in the afternoon. These derived means are included because they were provided by the vendor. If the sponsor had calculated the means, then these results would be represented in an ADaM datset .
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Rows 1, 6: | Shows the Number of Puff taken in the time interval specified in FADTC and FAENDTC. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken. | Rows 2-5 | Show the various measurements recorded for subject 3001 for Puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC provides the timing of each puff. | Rows 7-10 | Show the various measurements recorded for subject 3001 for Puff 10 during the afternoon administration of the tobacco product. FADTC and FAENDTC provides the timing of each puff. Note the data for PUFFS 2-9 are not shown to save space. | Row 11 | Shows the mean puff volume for subject 3001. The means for the other tests are not shown. FACOLSRT indicates that this result is a calculated as a Mean. | Rows 12-15 | Shows the various measurements recorded for subject 4001. Only a few rows are shown to save space. |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | FASEQ | FALNKID | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU | FACOLSRT | FALOBXFL | VISITNUM | FADTC | FAENDTC | FATPT |
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1 | TGI400 | FA | 3001 | PUFANYXYZ | 1 |
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| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
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| 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 | AM | 2 | TGI400 | FA | 3001 | PUFANYXYZ | 2 | 1 | PUFF 1 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 66.7 | ml/sec | 98 | ml/sec |
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| 2 | 2020-07-15T9:00 |
| AM | 3 | | FA | 3001 | PUFANYXYZ | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| AM | 4 | | FA | 3001 | PUFANYXYZ | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| AM | 5 | | FA | 3001 | PUFANYXYZ | 5 | 1 | PUFF 1 | PUFFDUR | Puff Duration | e-nicotine liqui | PUFF TOPOGRAPHY |
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| 6 | TGI400 | FA | 3001 | PUFANYXYZ | 6 |
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| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
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| 7 | | FA | 3001 | PUFANYXYZ | 7 | 2 | PUFF 10 | INTPUFIN | Puff Interval | e-nicotine liqui | PUFF TOPOGRAPHY |
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| AM | 8 | | FA | 3001 | PUFANYXYZ | 8 | 2 | PUFF 10 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 43 | ml/sec | 43 | ml/sec |
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| 2 | 2020-07-15T9:11 |
| AM | 9 | | FA | 3001 | PUFANYXYZ | 9 | 2 | PUFF 10 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| 10 | | FA | 3001 | PUFANYXYZ | 10 | 2 | PUFF 10 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| 11 | | FA | 3001 | PUFANYXYZ | 11 |
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| PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 53.7 | ml/sec | 53.7 | ml/sec | MEAN |
| 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 | AM | 12 | TGI400 | FA | 4001 | PUFANYXYZ | 1 |
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| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
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| 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 | AM | 13 | | FA | 4001 | PUFANYXYZ | 2 | 1 | PUFF 1 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 2 | sec | 2 | sec |
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| 2 | 2020-07-22 |
| AM | 14 | | FA | 4001 | PUFANYXYZ | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
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| 2 | 2020-07-22 |
| AM | 15 | | FA | 4001 | PUFANYXYZ | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
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| 2 | 2020-09-22T9:13 | 2020-09-22T9:30 | AM |
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The RELREC dataset was used to record the relationship between the Exposure records in EX and the records in FAEX.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | TD23 | EX |
| EXLNKID |
| ONE | EXFA1 | 2 | TD23 | FAEX |
| FALNKID |
| MANY | EXFA1 | |
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