This is a study were where subjects were randomized to use 3 different concentration concentrations of nicotine e-nicotine 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 clinical clinic for one 1 day. They were required to not use any e-cigarettes 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.
Device Identifiers (DI), a A Study Reference domain, DI, was used to identify the device used to measure puff topography. The provide This provides a consistent sponsor-defined 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.
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | 1 | TOPT001 | DI | PUFANYXYZ | 1 | DEVTYPE | Device Type | PUFF TOPOGRAPHER TOPOGRAPHY ANALYZER | 2 | TOPT001 | DI | PUFANYXYZ | 2 | MODEL | Model | PUFFALYZER 900 | 3 | TOPT001 | DI | PUFANYXYZ | 3 | MANUF MANUF | Manufacturer Manufacturer | ACME |
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The sponsor applicant submitted the EX domain to represent the usage of the e-cigarettes. For each subject, the usage for the two weeks are represented, and then the specified usage Exposure (EX) domain to represent use of the tobacco product. Usage for the 2-week period is represented for each subject, along with the specified use during the in-clinic visit are shown. The sponsor applicant elected not to represent each puff in this EX dataset. Each Puff , although each puff could have been recorded.
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | EXSEQ |
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SPTOBID | EXLNKID | EXTRT | EXDOSE | EXDOSTXT | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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1 | TOPT001 | EX | 3001 | 1nicotine INHALED |
| CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 2020-06-26 | 2020-07-14 | 2 | TENDS012nicotine PUFFS | CARTRIDGE | RESPIRATORY (INHALATION) | INHALED | 8 | mg/mL | 2020-07-15T9:00 | 2020-07-15TT9:45 | 3 | TOPT001 | EX | 3001 | 3nicotine AD LIBITUM | | 10 |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | INHALED15TT94515T259TENDS0143001 | 2nicotine 10PUFFS | INHALED |
| CARTRIDGE | RESPIRATORY (INHALATION) | 16 | 80715T3:000715TT3:45TENDS011nicotine AD LIBITUM | 10 |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | INHALED0622TENDS0121nicotine PUFFS |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | INHALED22T922T933001 | 3 | EC-333 | e-nicotine liquid | AD LIBITUM | INHALED | 8 | mg/mL | | 5004 |
| 1 |
| Cigarettes Brand XYZ |
| AD LIBITUM |
| CIGARETTE | RESPIRATORY (INHALATION) | 12.1 | mg/cigarette | 2020-10-08 | 2020-10-22 | 8 | TOPT001 | EX | 5004 |
| 2 | 1 | Cigarettes Brand XYZ | 10 |
| PUFF | CIGARETTE | RESPIRATORY (INHALATION) | 12.1 | mg/cigarette | 2020-10-22T9:00 | 2020-09-22T9:3115T2597TENDS0140014EC-333 | e-nicotine liquidPUFFS | INHALED |
| PUFF | CIGARETTE | RESPIRATORY (INHALATION) | 12.1 | 16mL0910-22T3:00 | 2020-09-22T3:30 |
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The FAEX domain was used to represent the puff topography associated with the in-clinic visit. . The Findings About Events or Interventions structure ("FA structure") is used to represent collected data that are findings 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. Additionally , the vendor provided the mean puff volume and the mean puff duration for the 10 puffs in the session. . Only selected data for 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, applicants derive summary results using 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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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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Row Shows Number Puff puffs taken in the time interval specified in FADTC and FAENDTC. This was | pre-specified prespecified in the design, but the | sponsor applicant reported the actual number of puffs taken. | Rows 2- | 3, -6 puff volume for Subject various measurements recorded for subject 3001 for | each puff and the puff duration for Subject 4001. puff 1 during the morning administration of the tobacco product. FADTC and FAENDTC | provides provide the timing of each puff. | Only The individual puff data for | 2 puffs the afternoon are not shown. | 4 & Shows the mean puff volume for Subject 3001 and the mean puff duration for Subject 4001for all puffs during the interval provided in FADTC and FAENDTC. The NSV variable FACOLSRT indicates that the Mean puff volume is provided. The method to calculate the mean was provided in FAMETHOD, in this situation the DEVICE ALGORITHM. 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: 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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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | SPTOBID | FASEQ | FALNKID | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU |
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FALOBXFL | FAMETHOD | VISITNUM | FADTC | FAENDTC | FATPT |
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FACOLSRTTGI400TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 1 | 1 |
| PUFF TOT |
TOTAL NUMBER OF PUFFS | Total Number of Puffs | Nicotine e- | nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS | 2 | 2020-07- | 15T915T09:00 | 2020-07-15TT9:45 | AM | 2 | TGI400TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 2 | 1 | PUFF 1 | PUFFVOL PUFF VOLUMEnicotine 66ml98ml15T9:0015T09:01.36 | 2020-07-15T09:01.38 | AM | 3 | TGI400 | FA | 3001 | PUFANYXYZ | EC-333 | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | Nicotine 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 | TGI400TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | Nicotine 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 | TGI400TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 5 | 1 | PUFF 1 | PUFFDUR | Puff Duration | Nicotine e- | nicotine liquiliquid | PUFF TOPOGRAPHY | 2.0 | msec | 1.6 | msec | 2 | 2020-07-15T09:01.36 | 2020-07-15T09:01.38 | AM | 6 | TGI4001 2INTPUFIN | Puff Interval | e-nicotine liqui | PUFF TOPOGRAPHY | AM | 7 | 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 | TGI4001 2PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liqui | PUFF TOPOGRAPHY | 9 | AM | 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 |
8 | TGI4001 2 PUFFVOL PUFF VOLUME nicotine mlml15T9:11AM | 3 | 15T03:30:34 | 2020-07-15T03:30:36 | PM | 9 | | TGI400 | FA | 3001 | PUFANYXYZ | EC-333 | 9 | 2 | PUFF | 210 | AVGFLOW | Average Flow rate | Nicotine e- | nicotine 4 | | FA | 3001 | PUFANYXYZ | 10 | PUFF 2 | PKFLOW | Peak Flow Rate | e-nicotine 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 |
5 | TGI40011 2PUFFDUR | Puff Duration | PKFLOW | Peak Flow Rate | Nicotine e- | nicotine liqui6 | | FA | 3001 | PUFANYXYZ | 12 | PUFF 2 | INTPUFIN | Puff Interval | e-nicotine liqui | 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- |
3 | | FA | 3001 | PUFANYXYZ | 13 | PUFFVOL | PUFF VOLUME | e-nicotine 53.7 | ml/sec | 53.7 | ml/sec | DEVICE ALGORITHM0707MEANTGI4004 | | FA | 4001 | PUFANYXYZ | EC-333 | 2 | 1 | PUFF 1 | PUFFDURPUFF DURATIONnicotine 2234 | mL/sec | 2 | 2020-08-15T09:01.36 | 2020- | 07-225TGI4002 2 PUFFDUR | PUFF DURATION | AVGFLOW | Average Flow rate | Nicotine e- | nicotine 18185 | mL/sec | 2 | 2020-08-15T09:01.36 | 2020- | 07-226TGI4003 | PUFFDUR | PUFF DURATION | EC-333 | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | Nicotine e- | e-nicotine 1818DEVICE ALGORITHM0922T9130922T930MEAN | AM | | Nsvmeta |
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| Variable | Label | Type | Role | CODELIST | Origin |
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FACOLSRT | Collected Summary Result Type | text | Non-standard Record Qualifier | (COLSTYP) | CRF |
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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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