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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 Typically, 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 . 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,
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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 76-10 | 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. | 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 |
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FACOLSRT | 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 | 2020-07-15T9:00 | 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 |
| 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| liquid | PUFF TOPOGRAPHY |
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| | 6 | TGI400 | FA | 3001 | PUFANYXYZ | 6 | 2 |
| 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 |
| 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 |
11 | FA | 3001 | PUFANYXYZ | 11 | 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 |
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| | 12 | TGI400 | FA | 4001 | PUFANYXYZ | 1 | 1 |
| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
| 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 |
| 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 |
| 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 |
| 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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