Page History

...

Dataset wrap

Name	pt

Rowcaps

Rows 1-9:	Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test.
Rows 10-19:	Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.
Rows 20-27:	Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	STOCONID	PTSEQ	PTREFID	PTGRPID	PTTESTCD	PTTEST	PTORRESU	PTSTRESU	PTSPEC	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	211	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	1	Week 0	1
2	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	212	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	2	Week 0	1
3	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	213	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	3	Week 0	1
4	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	214	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	1	Week 24	4
5	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	215	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	2	Week 24	4
6	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	216	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	3	Week 24	4
7	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	217	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	1	Week 52	9
8	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	218	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	2	Week 52	9
9	TOB07	PT	111	E-Liquid Standard (Long Term) Condition	219	VAP77777.1	1	NIC	Nicotine	mg/mL	mg/mL	E-LIQUID	3	Week 52	9
10	TOB07	PT	111	E-Vapor Standard Aerosol Condition	220	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 0	1
11	TOB07	PT	111	E-Vapor Standard Aerosol Condition	221	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 0	1
12	TOB07	PT	111	E-Vapor Standard Aerosol Condition	222	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 0	1
13	TOB07	PT	111	E-Vapor Standard Aerosol Condition	223	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 24	4
14	TOB07	PT	111	E-Vapor Standard Aerosol Condition	224	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 24	4
15	TOB07	PT	111	E-Vapor Standard Aerosol Condition	225	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 24	4
16	TOB07	PT	111	E-Vapor Standard Aerosol Condition	226	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 52	9
17	TOB07	PT	111	E-Vapor Standard Aerosol Condition	227	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 52	9
18	TOB07	PT	111	E-Vapor Standard Aerosol Condition	228	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 52	9
19	TOB07	PT	111	E-Vapor Standard Aerosol Condition	229	VAP77777.1	3	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 0	1
20	TOB07	PT	111	E-Vapor Intense Aerosol Condition	230	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 0	1
21	TOB07	PT		E-Vapor Intense Aerosol Condition	231	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 0	1
22	TOB07	PT		E-Vapor Intense Aerosol Condition	232	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 24	4
23	TOB07	PT		E-Vapor Intense Aerosol Condition	233	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 24	4
24	TOB07	PT		E-Vapor Intense Aerosol Condition	234	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 24	4
25	TOB07	PT		E-Vapor Intense Aerosol Condition	235	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	1	Week 52	9
26	TOB07	PT		E-Vapor Intense Aerosol Condition	236	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	2	Week 52	9
27	TOB07	PT		E-Vapor Intense Aerosol Condition	237	VAP77777.1	4	NIC	Nicotine	mg/puff	mg/puff	AEROSOL	3	Week 52	9

The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.

The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above.
(We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU)

Update the DI and DU. Check on the Aerosol Intense Condition.

Dataset wrap

title	lb.xpt
Name	di

Dataset2

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	PUFFMASTER3K	1	DEVTYPE	Device Type	Smoking Machine
2	TOB07	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme
3	TOB07	DI	PUFFMASTER3K	3	TRADENAM	Trade Name	PuffMaster 3000

Dataset wrap

Name	du

Dataset2

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	PUFFMASTER3K	1	Medium Intensity Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	TOB07	DU	PUFFMASTER3K	2	Medium Intensity Regimen		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	TOB07	DU	PUFFMASTER3K	3	Medium Intensity Regimen		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	TOB07	DU	PUFFMASTER3K	4	Medium Intensity Regimen		PUFFBLCK	Puff Block	25	%	25	25	%
5	TOB07	DU	PUFFMASTER3K	5	Medium Intensity Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
6	TOB07	DU	PUFFMASTER3K	6	Medium Intensity Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	TOB07	DU	PUFFMASTER3K	7	Medium Intensity Regimen		PUFFRNG	Puff Range	100-200		100-200
8	TOB07	DU	PUFFMASTER3K	8	Medium Intensity Regimen	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	TOB07	DU	PUFFMASTER3K	9	Medium Intensity Regimen	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF

Dataset wrap

Name	es

Dataset2

Row	STUDYID	DOMAIN	STOCONID	ESSEQ	ESPARMCD	ESPARM	ESVAL	ESVALU
1	TOB07	ES

Dataset wrap

Name	tc

Dataset2

Row	STUDYID	DOMAIN	RDOMAIN	TCVAR1	TCVRVAL1	TCSEQ	TCGRPID	TCPARMCD	TCPARM	TCVAL	TCVALU
1	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	1	PUFFPROF	Puff Profile	SQUARE	2	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	2	PUFFDUR	Puff Duration	1.25	sec	3	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	3	PUFFINT	Puff Interval	3	PUFF/min	4	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	4	PUFFBLCK	Puff Block	25	%	5	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	51	HUMID	Humidity	37	%
2	TOB07	ES	NUMPUFF	Total Number of Puffs	200	PUFF	6	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	62	PUFFVOLTEMP	Puff VolumeTemperature	1024	mLC
73	TOB07	TC	PT		ES	E-Vapor Standard Aerosol Condition	1	HUMID	Humidity	85	%
4	TOB07	ESPTTSTCND	E-Liquid Standard (Long Term) Vapor Standard Aerosol Condition	72	PUFFRNG	Puff Range	100-200
8	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	8	1	PUFFPAUS	Puff Pause	60	s
TEMP	Temperature	27	C
5	TOB07	ES	E-Vapor Intense Aerosol Condition	1	HUMID	Humidity	85	%
6	TOB07	ES	E-Vapor Intense Aerosol Condition	2	TEMP	Temperature	27	C	9	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	9	1	PUFFPINT	Puff Pause Interval	10	PUFF

Page tree

Versions Compared

Old Version 50

New Version 51

Key