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A Study Reference domain, DI, was used to identify the device used to measure puff topography. This provides a consistent sponsor-defined variable consistent 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 TOPOGRAPHY ANALYZER | 2 | TOPT001 | DI | PUFANYXYZ | 2 | MODEL | Model | PUFFALYZER 900 | 3 | TOPT001 | DI | PUFANYXYZ | 3 | MANUF | Manufacturer | ACME |
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The sponsor applicant submitted the EX
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-80 |
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domain t
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 | SDTM-715 |
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o represent the usage of the tobacco product. For each subject, the usage for the two week period are represented, and then the specified usage during the in-clinic visit are shown. The
sponsor applicant elected not to represent each puff in this EX dataset. Each Puff could have been recorded.
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A puff-by puff analysis was performed. FATPT was used to represent the time point, in this case, AM and PM. Typically, the sponsor 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 sponsor applicant created an ADaM dataset to represent the summary data ( Not Shown).
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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 sponsor 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 6-10: | 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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