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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Dataset2 |
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | 1 | TOPT001 | DI | PUFANYXYZ | 1 | DEVTYPE | Device Type | Puff Topography | | 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 applicant submitted the 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 The sponsor 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 during the in-clinic visit are shown. . The applicant elected not to represent each puff in this EX dataset, although each puff could have been recorded.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | EXSEQ |
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SPTOBIDEXLNKID | 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 | TENDS012 | nicotine PUFFS |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | INHALED | 8 | mg/mL | 2020-07-15T9:00 | 2020-07-15TT9:45 | 3 | TENDS014001 | 3 | 3001 | EC-333 | 3 | 2 | Nicotine e-liquid | 10 |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 2020-07-15T3:00 | 2020-07-15TT3:45 | 4 | TOPT001 | EX | 4001 | EC-333 | 1 |
| Nicotine e- | nicotine INHALED
| CARTRIDGE | RESPIRATORY (INHALATION) | 16 | mg/mL | 2020-09-06 | 2020-09-22 | 3TENDS01 | EC-333 | 2 | 1 | Nicotine e-liquid | 10 |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | 16 | mg/mL | 2020-09-22T9:00 | 2020-09-22T9:30 | 6 | TOPT001 | EX | 4001 | 4nicotine PUFFS |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) | INHALED | 16 | mg/mL | 2020-09-22T3:00 | 2020-09-22T3:30 | 7 | TOPT001 | EX | 5004 |
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| 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 | 2020-09-22T9:30 | 9 | TOPT0011 | EX | 5004 |
| 3 | 2 | Cigarettes Brand XYZ | 10 |
| PUFF | CIGARETTE | RESPIRATORY (INHALATION) | 12.1 | mg/cigarette | 2020-10-22T3:00 | 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 & 7 7-10: | 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: 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. | 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. |
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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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FACOLSRT | TGI400TOPT001 | 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 | 1TGI400TOPT001 | FA | 3001 | PUFANYXYZ | EC-333 | 2 | PUFFVOL VOLUME1 | PUFFVOL | Puff Volume | Nicotine e- | nicotine 66ml98mlmL/sec | 2 | 2020-07-15T09:01.36 | 2020-07- | 15T900PUFF 1 | 2 | TGI400PUFFVOL VOLUME 1 | AVGFLOW | Average Flow rate | Nicotine e- | nicotine 43ml43ml15T9:11PUFF 2 | 3 | 15T09:01.36 | 2020-07-15T09:01.38 | AM | 4 | TOPT001 | TGI400PUFFVOL VOLUME1 | PKFLOW | Peak Flow Rate | Nicotine e- | nicotine 537ml537mlDEVICE ALGORITHM15T90015TT945MEAN4TGI40040013001 | PUFANYXYZ | EC-333 | 5 | 1 | PUFF 1 | PUFFDUR | PUFF DURATIONPuff 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- | nicotine 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- | 22PUFF 1 | 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- |
5 | | FA | 4001 | PUFANYXYZ | 2 | PUFFDUR | PUFF DURATION | e-nicotine 18185 | mL/sec | 2 | 2020-07-15T03:30:34 | 2020-07 | -22PUFF 2 | -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 | |
6 | TGI4003 | PUFFDUR | PUFF DURATION | EC-333 | 2 | 1 | PUFF 1 | PUFFVOL | Puff Volume | Nicotine e- | e-nicotine 1.8 | sec | 1.8 | sec | 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 | DEVICE ALGORITHM0922T9130922T930MEAN | nsvmeta | Domain | | 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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The RELREC dataset was used to record the relationship between the records in EX and the records in FAEX.
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | TD23 | EX |
| EXLNKID |
| ONE | EXFA1 | 2 | TD23 | FAEX |
| FALNKID |
| MANY | EXFA1 | 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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