This is a study were subjects were randomized to use 3 different concentration of e-nicotine liquid, or their usual brand of cigarettes. 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 tobacco products 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/usual brand of cigarettes 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.
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The sponsor submitted the EX domain to represent the usage of the e-cigarettestobacco product. 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 | 7 | TENDS01 | EX | 5004 | 1 |
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| Cigarettes Brand XYZ | AD LIBITUM |
| INHALED | 12.1 | mg/cigarette | 2020-10-08 | 2020-10-22 | 8 | TENDS01 | EX | 5004 | 2 |
| 1 | Cigarettes Brand XYZ | 10 | PUFFS | INHALED | 12.1 | mg/cigarette | 2020-10-22T9:00 | 2020-09-22T9:30 | 9 | TENDS01 | EX | 5004 | 3 |
| 2 | Cigarettes Brand XYZ | 10 | PUFFS | INHALED | 12.1 | mg/cigarette | 2020-10-22T3:00 | 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. Typically, the sponsor derives summary results using the individual source data records, these summary results are represented in ADaM. However, if summary results are collected on a CRF or provided by an external vendor. these derived results can be represented in FAEX using the variable FACOLSRT. In this example, the sponsor created an ADaM dataset to represent the summary data ( Not Shown) .
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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. The individual puff data for the afternoon are not shown. | Rows 6-10 | 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. The individual puff data for the morning session are not shown. Note the data for PUFFS 2-9 are not shown to save space. | Rows 12-15 | Shows the various measurements recorded for subject 4001. Only a few rows are shown to save space. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | FASEQ | FALNKID | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU | FALOBXFL | VISITNUM | FADTC | FAENDTC | FATPT |
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1 | TGI400 | FA | 3001 | PUFANYXYZ | 1 | 1 |
| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
| 2 | 2020-07- | 15T915T09:00 | 2020-07-15TT9:45 | AM | 2 | TGI400 | FA | 3001 | PUFANYXYZ | 2 | 1 | PUFF 1 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 6698ml15T9:0015T09:01.36 | 2020-07-15T09:01.38 | AM | 3 | | FA | 3001 | PUFANYXYZ | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY | 15.5 | mL/sec | 15.5 | mL/sec |
| 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | 4 | | FA | 3001 | PUFANYXYZ | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY | 20.5 | mL/sec | 20.5 | mL/sec |
| 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | 5 | | FA | 3001 | PUFANYXYZ | 5 | 1 | PUFF 1 | PUFFDUR | Puff Duration | e-nicotine liquid | PUFF TOPOGRAPHY | 2.0 | msec | 1.6 | msec |
| 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | 6 | TGI400 | FA | 3001 | PUFANYXYZ | 6 | 2 |
| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10109 | PUFFS |
| 2 | 2020-07-15T03:00 | 2020-07-15T03:30 | PM | 7 | | FA | 3001 | PUFANYXYZ | 7 | 2 | PUFF 10 | INTPUFIN | Puff Interval | e-nicotine | liquiAM910396.8 | sec | 910396.8 | sec |
| 2 | 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | 8 | | FA | 3001 | PUFANYXYZ | 8 | 2 | PUFF 10 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 43 | ml/sec | 43 | ml/sec |
| 2 | 2020-07-15T03:30:34 | 2020-07- | 15T911AMPM | 9 | | FA | 3001 | PUFANYXYZ | 9 | 2 | PUFF 10 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | 10 | | FA | 3001 | PUFANYXYZ | 10 | 2 | PUFF 10 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | 12 | TGI400 | FA | 4001 | PUFANYXYZ | 1 | 1 |
| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
| 2 | 2020- | 070708-15TT9:45 | AM | 13 | | FA | 4001 | PUFANYXYZ | 2 | 1 | PUFF 1 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 2 | sec | 2 | sec |
| 2 | 2020 | -07-22-08-15T09:01.36 | 2020-08-15T09:01.38 | AM | 14 | | FA | 4001 | PUFANYXYZ | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
| 2 | 2020- | 07-2208-15T09:01.36 | 2020-08-15T09:01.38 | AM | 15 | | FA | 4001 | PUFANYXYZ | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
| 2 | 2020- | 0922T9130922T930
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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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