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A puff-by puff analysis was performed. Only selected data for Puff 1 and 10 are shown. No data are shown for 2-9 to simplify dataset review. FATPT was used to represent the time point, in this case, AM and PM. Typically, the applicant 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 applicant created an ADaM dataset to represent the summary data ( Not Shown).
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-288 |
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| Rowcaps |
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| Rows 1, 6: | Show the Number of Puffs taken in the time interval specified in FADTC and FAENDTC. This was pre-specified in the design, but the applicant 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 provide the timing of each puff. The individual puff data for the afternoon are not shown. | | Rows 67-10: | Show the various measurements recorded for subject 3001 for Puff 10 during the afternoon administration of the tobacco product. FADTC and FAENDTC provide 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 simplify dataset review. | | Rows 12-15: | Show the various measurements recorded for subject 4001. Only a few rows are shown to simplify dataset review. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | SPTOBID | FASEQ | FALNKID | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU | VISITNUM | FADTC | FAENDTC | FATPT |
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| 1 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 1 | 1 |
| PUFF TOT | Total Number of Puffs | Nicotine e-liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS | 2 | 2020-07-15T09:00 | 2020-07-15TT9:45 | AM | | 2 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 2 | 1 | PUFF 1 | PUFFVOL | Puff Volume | Nicotine e-liquid | PUFF TOPOGRAPHY | 36.7 | mL/sec | 37 | mL/sec | 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | | 3 | | FA | 3001 | PUFANYXYZ | EC-333 | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | Nicotine e-liquid | PUFF TOPOGRAPHY | 15.5 | mL/sec | 15.5 | mL/sec | 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | | 4 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | Nicotine e-liquid | PUFF TOPOGRAPHY | 20.5 | mL/sec | 20.5 | mL/sec | 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | | 5 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 5 | 1 | PUFF 1 | PUFFDUR | Puff Duration | Nicotine e-liquid | PUFF TOPOGRAPHY | 2.0 | msec | 1.6 | msec | 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | | 6 | | FA | 3001 | PUFANYXYZ | EC-333 | 6 | 2 |
| PUFF TOT | Total Number of Puffs | e-nicotin liquid | PUFF TOPOGRAPHY | 9 | PUFFS | 9 | PUFFS | 2 | 2020-07-15T03:00 | 2020-07-15T03:30 | PM | | 7 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 7 | 2 | PUFF 10 | INTPUFIN | Puff Interval | Nicotine e-liquid | PUFF TOPOGRAPHY | 910396.8 | sec | 910396.8 | sec | 2 | 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | | 8 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 8 | 2 | PUFF 10 | PUFFVOL | Puff Volume | Nicotine e-liquid | PUFF TOPOGRAPHY | 43 | mL/sec | 43 | mL/sec | 2 | 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | | 9 | | FA | 3001 | PUFANYXYZ | EC-333 | 9 | 2 | PUFF 10 | AVGFLOW | Average Flow rate | Nicotine e-liquid | PUFF TOPOGRAPHY | 14.5 | mL/sec | 14.5 | mL/sec | 2 | 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | | 10 | TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 10 | 2 | PUFF 10 | PKFLOW | Peak Flow Rate | Nicotine e-liquid | PUFF TOPOGRAPHY | 22.5 | mL/sec | 22.5 | mL/sec | 2 | 2020-07-15T03:30:34 | 2020-07-15T03:30:36 | PM | | 12 | TOPT001 | FA | 4001 | PUFANYXYZ | EC-333 | 1 | 1 |
| PUFF TOT | Total Number of Puffs | Nicotine e-liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS | 2 | 2020-08-15T9:00 | 2020-08-15TT9:45 | AM | | 13 | | FA | 4001 | PUFANYXYZ | EC-333 | 2 | 1 | PUFF 1 | PUFFVOL | Puff Volume | Nicotine e-liquid | PUFF TOPOGRAPHY | 34.7 | mL/sec | 34 | mL/sec | 2 | 2020-08-15T09:01.36 | 2020-08-15T09:01.38 | AM | | 14 | TOPT001 | FA | 4001 | PUFANYXYZ | EC-333 | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | Nicotine e-liquid | PUFF TOPOGRAPHY | 15.5 | mL/sec | 15.5 | mL/sec | 2 | 2020-08-15T09:01.36 | 2020-08-15T09:01.38 | AM | | 15 | TOPT001 | FA | 4001 | PUFANYXYZ | EC-333 | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | Nicotine e-liquid | PUFF TOPOGRAPHY | 23.5 | mL/sec | 23.5 | mL/sec | 2 | 2020-08-15T09:01.36 | 2020-08-15T09:01.38 | AM |
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