This is a study where subjects were randomized to 3 different concentrations of nicotine e-liquid, or their usual brand of cigarettes. The subject subjects used the product at home for 2 weeks. This 2-week period allowed subjects to become familiar with the e-cigarette. After two 2 weeks, the subjects were confined to the clinic for one 1 day. They were required to not use any tobacco products for 12 hours prior to the visit. Subjects had to have CO level levels below a pre-specified prespecified level , to attend the visit. If the level , was too high, the visit was re-scheduledrescheduled. 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.
A Device Identifiers (DI), a Study Reference domain, DI, was used to identify the device used to measure puff topography. This provides a consistent variable consistent variable (SPDEVID) for linking data. Device Because device identifiers exist independently from subjects; therefore, the DI domain does not contain USUBJID. Only one 1 device was used for all subjects in the study.
...
The applicant submitted the Exposure (EX)
Jira |
---|
showSummary | false |
---|
server | Issue Tracker (JIRA) |
---|
serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
---|
key | TOBA-80 |
---|
|
domain
tto Jira |
---|
showSummary | false |
---|
server | Issue Tracker (JIRA) |
---|
serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
---|
key | SDTM-715 |
---|
|
o represent
the usage use of the tobacco product.
For each subject, the usage Usage for the
two 2-week period
are is represented
, and then for each subject, along with the specified
usage use during the in-clinic visit
are shown. The applicant elected not to represent each puff in this EX dataset
. Each Puff , although each puff could have been recorded.
...
The FAEX domain was used to represent the puff topography associated with the in-clinic visit. The Findings About Events or Interventions structure (or "FA structure") is used to represent collected data that are findings about” about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. Not all findings associated with an event or intervention should be represented in the FA structure.
A puff-by puff analysis was performed. Only selected data for Puff puffs 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 applicants derive 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 Shownnot shown).
Dataset wrap |
---|
|
Jira |
---|
showSummary | false |
---|
server | Issue Tracker (JIRA) |
---|
serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
---|
key | TOBA-288 |
---|
|
Rowcaps |
---|
Rows 1, 6: | Show the Number number of Puffs puffs taken in the time interval specified in FADTC and FAENDTC. This was pre-specified prespecified 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 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 7-10: | Show the various measurements recorded for subject 3001 for Puff 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 : Data for Puffs 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. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | SPDEVID | SPTOBID | FASEQ | FALNKID | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU | VISITNUM | FADTC | FAENDTC | FATPT |
---|
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 |
|
|
The RELREC dataset was used to record the relationship between the Exposure records in EX and the records in FAEX.
...