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Dataset wrap

Name	di

Dataset2

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	ACME

The sponsor submitted the EX domain to represent the usage of the tobacco product. 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.

Dataset wrap

Name	ex

Dataset2

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	SPTOBID	EXLNKID	EXTRT	EXDOSE	EXDOSU	EXROUTE	EXPSTRG	EXPSTRGU	EXSTDTC	EXENDTC
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	1	e-nicotine liquid	10	PUFFS	INHALED	8	mg/mL	2020-07-15T9:00	2020-07-15TT9:45
3	TENDS01	EX	3001	3	EC-333	2	e-nicotine liquid	10	PUFFS	INHALED	8	mg/mL	2020-07-15T3:00	2020-07-15TT3:45
4	TENDS01	EX	4001	1	EC-333		e-nicotine liquid	AD LIBITUM		INHALED	16	mg/mL	2020-09-06	2020-09-22
5	TENDS01	EX	4001	2	EC-333	1	e-nicotine liquid	10	PUFFS	INHALED	16	mg/mL	2020-09-22T9:00	2020-09-22T9:30
6	TENDS01	EX	4001	3	EC-333	2	e-nicotine liquid	10	PUFFS	INHALED	16	mg/mL	2020-09-22T3:00	2020-09-22T3:30
7	TENDS01	EX	5004	1			Cigarettes Brand XYZ	AD LIBITUM		INHALED	12.1	mg/cigarette	2020-10-08	2020-10-22
8	TENDS01	EX	5004	2		1	Cigarettes Brand XYZ	10	PUFFS	INHALED	12.1	mg/cigarette	2020-10-22T9:00	2020-09-22T9:30
9	TENDS01	EX	5004	3		2	Cigarettes Brand XYZ	10	PUFFS	INHALED	12.1	mg/cigarette	2020-10-22T3:00	2020-09-22T3:30

The FAEX domain was used to represent the puff topography associated with the in-clinic visit. A puff -by puff analysis was performed. FATPT was used to represent the time point, in this case, AM and PM. Typically, the sponsor 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 created an ADaM dataset to represent the summary data ( Not Shown).

Dataset wrap

Name	faex

Rowcaps

Rows 1, 6:	Show the Number of Puff taken in the time interval specified in FADTC and FAENDTC. This was pre-specified in the design, but the sponsor 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 provides 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 provides 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 save space.
Rows 12-15:	Show the various measurements recorded for subject 4001. Only a few rows are shown to save space.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	SPTOBID	FASEQ	FALNKID	FASPID	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FAORRESU	FASTRESC	FASTRESU	VISITNUM	FADTC	FAENDTC	FATPT
1	TGI400	FA	3001	PUFANYXYZ	EC-333	1	1		PUFF TOT	Total Number of Puffs	e-nicotine liquid	PUFF TOPOGRAPHY	10	PUFFS	10	PUFFS	2	2020-07-15T09:00	2020-07-15TT9:45	AM
2	TGI400	FA	3001	PUFANYXYZ	EC-333	2	1	PUFF 1	PUFFVOL	Puff Volume	e-nicotine liquid	PUFF TOPOGRAPHY	36.7	mL/sec	37	mL/sec	2	2020-07-15T09:01.36	2020-07-15T09:01.38	AM
3	TGI400	FA	3001	PUFANYXYZ	EC-333	3	1	PUFF 1	AVGFLOW	Average Flow rate	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	TGI400	FA	3001	PUFANYXYZ	EC-333	4	1	PUFF 1	PKFLOW	Peak Flow Rate	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	TGI400	FA	3001	PUFANYXYZ	EC-333	5	1	PUFF 1	PUFFDUR	Puff Duration	e-nicotine liquid	PUFF TOPOGRAPHY	2.0	msec	1.6	msec	2	2020-07-15T09:01.36	2020-07-15T09:01.38	AM
6	TGI400	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	TGI400	FA	3001	PUFANYXYZ	EC-333	7	2	PUFF 10	INTPUFIN	Puff Interval	e-nicotine liquid	PUFF TOPOGRAPHY	910396.8	sec	910396.8	sec	2	2020-07-15T03:30:34	2020-07-15T03:30:36	PM
8	TGI400	FA	3001	PUFANYXYZ	EC-333	8	2	PUFF 10	PUFFVOL	Puff Volume	e-nicotine liquid	PUFF TOPOGRAPHY	43	mL/sec	43	mL/sec	2	2020-07-15T03:30:34	2020-07-15T03:30:36	PM
9	TGI400	FA	3001	PUFANYXYZ	EC-333	9	2	PUFF 10	AVGFLOW	Average 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	TGI400	FA	3001	PUFANYXYZ	EC-333	10	2	PUFF 10	PKFLOW	Peak Flow Rate	e-nicotine liquid	PUFF TOPOGRAPHY	22.5	mL/sec	22.5	mL/sec	2	2020-07-15T03:30:34	2020-07-15T03:30:36	PM
12	TGI400	FA	4001	PUFANYXYZ	EC-333	1	1		PUFF TOT	Total Number of Puffs	e-nicotine liquid	PUFF TOPOGRAPHY	10	PUFFS	10	PUFFS	2	2020-08-15T9:00	2020-08-15TT9:45	AM
13	TGI400	FA	4001	PUFANYXYZ	EC-333	2	1	PUFF 1	PUFFVOL	Puff Volume	e-nicotine liquid	PUFF TOPOGRAPHY	34.7	mL/sec	34	mL/sec	2	2020-08-15T09:01.36	2020-08-15T09:01.38	AM
14	TGI400	FA	4001	PUFANYXYZ	EC-333	3	1	PUFF 1	AVGFLOW	Average Flow rate	e-nicotine liquid	PUFF TOPOGRAPHY	15.5	mL/sec	15.5	mL/sec	2	2020-08-15T09:01.36	2020-08-15T09:01.38	AM
15	TGI400	FA	4001	PUFANYXYZ	EC-333	4	1	PUFF 1	PKFLOW	Peak Flow Rate	e-nicotine 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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