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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 TOPOGRAPHER | | 2 | TOPT001 | DI | PUFANYXYZ | 2 | MODEL | Model | PUFFALYZER 900 | | 3 | TOPT001 | DI | PUFANYXYZ | 3 | MANUF | Manufacturer | ACMEPuff Topography |
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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 sponsor elected not to represent each puff in this EX dataset. Each Puff could have been recorded. DEVTYP= PUFF TOPOGRAPHER MODEL= Puffalyzer 900 MANUF = ACME
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID |
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EXSPID| EXLNKID | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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| 1 | TOPT001 | EX | 3001 | 1 | EC-333 |
| e-nicotine liquid | AD LIBITUM |
| INHALED | 8 | mg/mL | 2020-06-26 | 2020-07-14 | | 2 | TENDS01 | EX | 3001 | 2 | EC-333 |
PUFF | 1 | e-nicotine liquid | 10 | PUFFS | INHALED | 8 | mg/mL | 2020-07-15T9:00 | 2020-07-15TT9:45 | | 3 | TOPT001 | EX | 3001 | 3 | EC-333 |
| e-nicotine liquid | AD LIBITUM |
| INHALED | 8 | mg/mL | 2020-07-15TT9:45 | 2020-07-15T2:59 | | 4 | TENDS01 | EX | 3001 | 4 | EC-333 | 2 | e-nicotine liquid | 10 | PUFFS | INHALED | 8 | mg/mL | 2020-07-15T3:00 | 2020-07-15TT3:45 | | 5 | TENDS01 | EX | 4001 |
3| 1 | EC-333 |
| e-nicotine liquid | AD LIBITUM |
| INHALED | 16 | mg/mL | 2020-09-06 | 2020-09-22 |
34PUFF | 1 | e-nicotine liquid | 10 | PUFFS | INHALED | 16 | mg/mL | 2020-09-22T9:00 | 2020-09-22T9:30 | | 3 | TOPT001 | EX | 3001 | 3 | EC-333 |
| e-nicotine liquid | AD LIBITUM |
| INHALED | 8 | mg/mL | 2020-09-22T9:31 | 2020-09-15T2:59 | | 7 | TENDS01 | EX | 4001 | 4 | EC-333 | 2 | e-nicotine liquid | 10 | PUFFS | INHALED | 16 | mg/mL | 2020-09-22T3:00 | 2020-09-22T3:30 |
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The FAEX domain was used to represent the puff topography associated with the in -clinic visit. 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.
inter-puff interval: sec average flow-rate (mL/s) peak flow rate (mL/s)
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| Row 1: | Shows the Number of Puff taken in the interval. This was pre-specified in the design, but the sponsor reported the actual number of puffs taken. | | Rows 2-3, 5-6 : | Show the puff volume for Subject 3001 for each puff and the puff duration for Subject 4001. FADTC and FAENDTC provides the timing of each puff. Only data for 2 puffs are shown. | | Rows 4 & 7: | 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 | FASEQ | FALNKID | FASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FAORRESU | FASTRESC | FASTRESU | FALOBXFL | FAMETHOD | VISITNUM | FADTC | FAENDTC | FATPT |
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| 1 | TGI400 | FA | 3001 | PUFANYXYZ | 1 |
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| PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liquid | PUFF TOPOGRAPHY | 10 | PUFFS | 10 | PUFFS |
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| 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 |
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| | 2 | TGI400 | FA | 3001 | PUFANYXYZ | 2 | 1 | PUFF 1 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 66.7 | ml/sec | 98 | ml/sec |
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| 2 | 2020-07-15T9:00 |
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| | 3 | | FA | 3001 | PUFANYXYZ | 3 | 1 | PUFF 1 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| | 4 | | FA | 3001 | PUFANYXYZ | 4 | 1 | PUFF 1 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| | 5 | | FA | 3001 | PUFANYXYZ | 5 | 1 | PUFF 1 | PUFFDUR | Puff Duration | e-nicotine liqui | PUFF TOPOGRAPHY |
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| | 6 | | FA | 3001 | PUFANYXYZ | 6 | 1 | PUFF 2 | INTPUFIN | Puff Interval | e-nicotine liqui | PUFF TOPOGRAPHY |
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| | 7 | | FA | 3001 | PUFANYXYZ | 7 | 1 | PUFF 2 | PUFF TOT | TOTAL NUMBER OF PUFFS | e-nicotine liqui | PUFF TOPOGRAPHY | 9 |
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| | 8 | | FA | 3001 | PUFANYXYZ |
3| 8 | 1 | PUFF 2 | PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 43 | ml/sec | 43 | ml/sec |
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| 2 | 2020-07-15T9:11 |
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| | 3 | | FA | 3001 | PUFANYXYZ | 9 |
| PUFF 2 | AVGFLOW | Average Flow rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| | 4 | | FA | 3001 | PUFANYXYZ | 10 |
| PUFF 2 | PKFLOW | Peak Flow Rate | e-nicotine liquid | PUFF TOPOGRAPHY |
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| | 5 | | FA | 3001 | PUFANYXYZ | 11 |
| PUFF 2 | PUFFDUR | Puff Duration | e-nicotine liqui | PUFF TOPOGRAPHY |
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| | 6 | | FA | 3001 | PUFANYXYZ | 12 |
| PUFF 2 | INTPUFIN | Puff Interval | e-nicotine liqui | PUFF TOPOGRAPHY |
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| | 3 | | FA | 3001 | PUFANYXYZ |
4| 13 |
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| PUFFVOL | PUFF VOLUME | e-nicotine liquid | PUFF TOPOGRAPHY | 53.7 | ml/sec | 53.7 | ml/sec |
| DEVICE ALGORITHM | 2 | 2020-07-15T9:00 | 2020-07-15TT9:45 | AM |
| MEAN | | 4 | | FA | 4001 | PUFANYXYZ | 1 |
| PUFF 1 | PUFFDUR | PUFF DURATION | e-nicotine liquid | PUFF TOPOGRAPHY | 2 | sec | 2 | sec |
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| 2 | 2020-07-22 |
PUFF 1
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| | 5 | | FA | 4001 | PUFANYXYZ | 2 |
| PUFF 2 | PUFFDUR | PUFF DURATION | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
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| 2 | 2020-07-22 |
PUFF 2
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| | 6 | | FA | 4001 | PUFANYXYZ | 3 |
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| PUFFDUR | PUFF DURATION | e-nicotine liquid | PUFF TOPOGRAPHY | 1.8 | sec | 1.8 | sec |
| DEVICE ALGORITHM | 2 | 2020-09-22T9:13 | 2020-09-22T9:30 | AM |
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| 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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| Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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| 1 | TD23 | EX |
| EXSPIDEXLNKID |
| ONE | EXFA1 | | 2 | TD23 | FAEX |
| FASPIDFALNKID |
| MANY | EXFA1 | |
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