Page History

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Dataset wrap

Name	tx

Rowcaps

Rows 1-

23:

17:	Show the experimental parameters that are common for Table 1 of Study 123.
Rows 18, 25:	Show that set A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A.
Rows 18-24:	Show trial set parameters and trial set values that comprise the test conditions for trial set

Show trial set parameters and trial set values that comprise the test conditions for trial set

A1. Set A1 is the data for the negative control (concentration 0) with short term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".

Set A1 is associated with the first row in the sample report table for

study

Study 123.

Rows

24

25-

46

31:	Show trial set parameters and trial set values that comprise the test conditions for trial set A2. Set A2 is the data for the short term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long

name (SET) equal to "ST+S9_C1250".

Set A2 is associated with the second row in the sample report table for study 123.

name (SET) equal to "ST+S9_C1250".

Set A2 is associated with the second row in the sample report table for Study 123.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1

Dataset2

1617181920212223Medium Intensity Regimen25262728293031323334353637383940414243444546

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A1	ST+S9_C0	2	METACT	Metabolic Activation	+S9
2	123	MNvit	TX	A1	ST+S9_C0	3	METACTFL	Y/N presence of metabolic activation	Y
3	123	MNvit	TX	A1	ST+S9_C0	4	TRTDMIN	Treatment Duration Minimum	3
4	123	MNvit	TX	A1	ST+S9_C0	5	TRTDTRG	Treatment Duration Target	3.5
5	123	MNvit	TX	A1	ST+S9_C0	6	TRTDMAX	Treatment Duration Maximum	4
6	123	MNvit	TX	A1	ST+S9_C0	7	TRTDU	Treatment Duration Unit	HOURS
7	123	MNvit	TX	A1	ST+S9_C0	8	RCVDMIN	Recovery Duration Minimum	23.5
8	123	MNvit	TX	A1	ST+S9_C0	9	RCVDTRG	Recovery Duration Target	24
9	123	MNvit	TX	A1	ST+S9_C0	10	RCVDMAX	Recovery Duration Maximum	24.5
10	123	MNvit	TX	A1	ST+S9_C0	11	RCVDU	Recovery Duration Unit	HOURS
11	123	MNvit	TX	A1	ST+S9_C0	12	INCBTMP	Incubation Temperature	37
12	123	MNvit	TX	A1	ST+S9_C0	13	INCBTMPU	Incubation Temperature Unit	C
13	123	MNvit	TX	A1	ST+S9_C0	14	HUMID	Atmospheric Relative Humidity Percent	50
14	123	MNvit	TX	A1	ST+S9_C0	15	ATMCO2	Atmospheric CO2 Percent	5
15	123	MNvit	TX	A1	ST+S9_C0	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	MNvit	TX	A1A	ST+S9_C0	17 1	EXPTYPMETACT	Exposure Type	Submerged	Metabolic Activation	+S9
2	123	MNvit	TX	A1A	ST+S9_C0	182	SAMTYP	Sample Type	Total Particulate Matter in DMSO	METACTFL	Y/N presence of metabolic activation	Y
3	123	MNvit	TX	A1A	ST+S9_C0	193	INTRVN	Name of the Intervention Article	Tobacco ProdA	TRTDMIN	Treatment Duration Minimum	3
4	123	MNvit	TX	A1A	ST+S9_C0	204	ITVTYPE	type of intervention article	Negative Control	TRTDTRG	Treatment Duration Target	3.5
5	123	MNvit	TX	A1A	ST+S9_C0	215	ITVCONC	Concentration of intervention article	0	TRTDMAX	Treatment Duration Maximum	4
6	123	MNvit	TX	A1A	ST+S9_C0	226	ITVCONCUTRTDU	Concentration Treatment Duration Unit	ug/mlHOURS
7	123	MNvit	TX	A1A	ST+S9_C0	237	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K	RCVDMIN	Recovery Duration Minimum	23.5
8	123	MNvit	TX	A1A	ST+S9_C0	248	DUREFID	Smoke Regimen	RCVDTRG	Recovery Duration Target	24
9	123	MNvit	TX	A2A	ST+S9_C1250	29	METACT	Metabolic Activation	+S9	RCVDMAX	Recovery Duration Maximum	24.5
10		123	MNvit	TX	A2A	ST+S9_C1250	310	METACTFL	Y/N presence of metabolic activation	Y	RCVDU	Recovery Duration Unit	HOURS
11		123	MNvit	TX	A2A	ST+S9_C1250	411	TRTDMIN	Treatment Duration Minimum	3	INCBTMP	Incubation Temperature	37
12		123	MNvit	TX	A2A	ST+S9_C1250	512	TRTDTRG	Treatment Duration Target	3.5	INCBTMPU	Incubation Temperature Unit	C
13		123	MNvit	TX	A2A	ST+S9_C1250	613	TRTDMAX	Treatment Duration Maximum	4	HUMID	Atmospheric Relative Humidity Percent	50
14		123	MNvit	TX	A2A	ST+S9_C1250	714	TRTDU	Treatment Duration Unit	HOURS	ATMCO2	Atmospheric CO2 Percent	5
15		123	MNvit	TX	A2A	ST+S9_C1250	815	RCVDMIN	Recovery Duration Minimum	23.5	SPTOBID	Sponsor defined tobacco identifier	CIG01a
16		123	MNvit	TX	A2A	ST+S9_C1250	916	RCVDTRG	Recovery Duration Target	24	EXPTYP	Exposure Type	Submerged
17		123	MNvit	TX	A2A	ST+S9_C1250	1017	RCVDMAX	Recovery Duration Maximum	24.5	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18		123	MNvit	TX	A2A1	ST+S9_C1250C0	11 1	RCVDU	Recovery Duration Unit	HOURS	PSETCD	Parent Set Code	A
19		123	MNvit	TX	A2A1	ST+S9_C1250CO	122	INCBTMP	Incubation Temperature	37	INTRVN	Name of the Intervention Article	Tobacco ProdA
20		123	MNvit	TX	A2A1	ST+S9_C1250C0	133	INCBTMPU	Incubation Temperature Unit	C	ITVTYPE	type of intervention article	Negative Control
21		123	MNvit	TX	A2A1	ST+S9_C1250C0	144	HUMID	Atmospheric Relative Humidity Percent	50	ITVCONC	Concentration of intervention article	0
22		123	MNvit	TX	A2A1	ST+S9_C1250C0	155	ATMCO2	Atmospheric CO2 Percent	5	ITVCONCU	Concentration Unit	ug/ml
23		123	MNvit	TX	A2A1	ST+S9_C1250C0	166	SPTOBID SPDEVID	Sponsor defined tobacco device identifierCIG01a	PUFFMASTER3K
24	123	MNvit	TX	A2A1	ST+S9_C1250C0	177	EXPTYP DUREFID	Exposure Type	Submerged	Smoke Regimen	Medium Intensity Regimen
25		123	MNvit	TX	A2	ST+S9_C1250	18 1	SAMTYP	Sample Type	Total Particulate Matter in DMSO	PSETCD	Parent Set Code	A
26		123	MNvit	TX	A2	ST+S9_C1250	192	INTRVN	Name of the Intervention Article	Tobacco ProdA
27	123	MNvit	TX	A2	ST+S9_C1250	203	ITVTYPE	type of intervention article	Product
28	123	MNvit	TX	A2	ST+S9_C1250	214	ITVCONC	Concentration of intervention article	1250
29	123	MNvit	TX	A2	ST+S9_C1250	225	ITVCONCU	Concentration Unit	ug/ml
30	123	MNvit	TX	A2	ST+S9_C1250	236	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
31	123	MNvit	TX	A2	ST+S9_C1250	247	DUREFID	Smoke Regimen	High Intensity Regimen

Dataset wrap

Name	relref

Rowcaps

Row 1:	Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of 'A1', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set.
Rows 2-5:	Show the values of four observational units C0_Count1 through C0_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt.
Row 6:	Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of 'A2', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set.
Rows 7-10:	Show the values of four observational units C1250_Count1 through C1250_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt.

Dataset2

tableid	relref

Row	STUDYID	GNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	MNvit	A1	C0		1	EXPERIMENTAL UNIT/TRIAL SET
2	123	MNvit	A1	C0-Count1	C0	2	OBSERVATIONAL UNIT
3	123	MNvit	A1	C0-Count2	C0	2	OBSERVATIONAL UNIT
4	123	MNvit	A1	C0-Count3	C0	2	OBSERVATIONAL UNIT
5	123	MNvit	A1	C0-Count4	C0	2	OBSERVATIONAL UNIT
6	123	MNvit	A2	C1250		1	EXPERIMENTAL UNIT/TRIAL SET
7	123	MNvit	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT
8	123	MNvit	A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9	123	MNvit	A2	C1250-Count3	C1250	2	OBSERVATIONAL UNIT
10	123	MNvit	A2	C1250-Count4	C1250	2	OBSERVATIONAL UNIT

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