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Dataset wrap

Name	tx.xpt

Rowcaps

Rows 1-24:

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 123.

Rows 25-47:

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.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A1	ST+S9_C0	2	METACT	Metabolic

Activation

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

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
16	123	MNvit	TX	A1	ST+S9_C0	17	EXPTYP	Exposure

Type

Type	Submerged
17	123	MNvit	TX	A1	ST+S9_C0	18

SAMTYP

SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	MNvit	TX	A1	ST+S9_C0	19	INTRVN	Name of the Intervention Article	Tobacco ProdA
19	123	MNvit	TX	A1	ST+S9_C0	20	ITVTYPE	type of intervention article	Negative Control
20	123	MNvit	TX	A1	ST+S9_C0	21	ITVCONC	Concentration of intervention article	0
21	123	MNvit	TX	A1	ST+S9_C0	22	ITVCONCU	Concentration Unit	ug/ml
22	123	MNvit	TX	A1	ST+S9_C0	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
23	123	MNvit	TX	A1	ST+S9_C0	24

DUREFID

DUREFID	Smoke Regimen	Medium Intensity Regimen
24	123	MNvit	TX	A2	ST+S9_C1250	2	METACT	Metabolic

Activation

Activation	+S9
25	123	MNvit	TX	A2	ST+S9_C1250	3	METACTFL	Y/N presence of metabolic

activation

activation	Y
26	123	MNvit	TX	A2	ST+S9_C1250	4	TRTDMIN	Treatment Duration Minimum	3
27	123	MNvit	TX	A2	ST+S9_C1250	5	TRTDTRG	Treatment Duration Target	3.5
28	123	MNvit	TX	A2	ST+S9_C1250	6	TRTDMAX	Treatment Duration Maximum	4
29	123	MNvit	TX	A2	ST+S9_C1250	7	TRTDU	Treatment Duration Unit	HOURS
30	123	MNvit	TX	A2	ST+S9_C1250	8	RCVDMIN	Recovery Duration Minimum	23.5
31	123	MNvit	TX	A2	ST+S9_C1250	9	RCVDTRG	Recovery Duration Target	24
32	123	MNvit	TX	A2	ST+S9_C1250	10	RCVDMAX	Recovery Duration Maximum	24.5
33	123	MNvit	TX	A2	ST+S9_C1250	11	RCVDU	Recovery Duration Unit	HOURS
34	123	MNvit	TX	A2	ST+S9_C1250	12	INCBTMP	Incubation Temperature	37
35	123	MNvit	TX	A2	ST+S9_C1250	13	INCBTMPU	Incubation Temperature Unit	C
36	123	MNvit	TX	A2	ST+S9_C1250	14	HUMID	Atmospheric Relative Humidity Percent	50
37	123	MNvit	TX	A2	ST+S9_C1250	15	ATMCO2	Atmospheric CO2 Percent	5
38	123	MNvit	TX	A2	ST+S9_C1250	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
39	123	MNvit	TX	A2	ST+S9_C1250	17	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
40	123	MNvit	TX	A2	ST+S9_C1250	18

SAMTYP

Sample Type

(e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical)

Total Particulate Matter in DMSO
41	123	MNvit	TX	A2	ST+S9_C1250	19	INTRVN	Name of the Intervention Article	Tobacco ProdA
42	123	MNvit	TX	A2	ST+S9_C1250	20	ITVTYPE	type of intervention article

choices of values: product; negative control; positive control

	Product
43	123	MNvit	TX	A2	ST+S9_C1250	21	ITVCONC	Concentration of intervention article	1250
44	123	MNvit	TX	A2	ST+S9_C1250	22	ITVCONCU	Concentration Unit	ug/ml
45	123	MNvit	TX	A2	ST+S9_C1250	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
46	123	MNvit	TX	A2	ST+S9_C1250	24	DUREFID	Smoke Regimen	High Intensity Regimen

Expand

title	tx.xpt (trial sets)

A1:

A2:

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	~~123~~	~~MNvit~~	TX	A1	ST+S9_C0	1	~~TESTSYS~~	~~Test system~~	~~TK6 Lymphoblastoid Suspension Cells~~
2	123	MNvit	TX	A1	ST+S9_C0	2	METACT	Metabolic Activation (this is the type of activation used)	+S9
3	123	MNvit	TX	A1	ST+S9_C0	3	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
4	123	MNvit	TX	A1	ST+S9_C0	4	TRTDMIN	Treatment Duration Minimum	3
5	123	MNvit	TX	A1	ST+S9_C0	5	TRTDTRG	Treatment Duration Target	3.5
6	123	MNvit	TX	A1	ST+S9_C0	6	TRTDMAX	Treatment Duration Maximum	4
7	123	MNvit	TX	A1	ST+S9_C0	7	TRTDU	Treatment Duration Unit	HOURS
8	123	MNvit	TX	A1	ST+S9_C0	8	RCVDMIN	Recovery Duration Minimum	23.5
9	123	MNvit	TX	A1	ST+S9_C0	9	RCVDTRG	Recovery Duration Target	24
10	123	MNvit	TX	A1	ST+S9_C0	10	RCVDMAX	Recovery Duration Maximum	24.5
11	123	MNvit	TX	A1	ST+S9_C0	11	RCVDU	Recovery Duration Unit	HOURS
12	123	MNvit	TX	A1	ST+S9_C0	12	INCBTMP	Incubation Temperature	37
13	123	MNvit	TX	A1	ST+S9_C0	13	INCBTMPU	Incubation Temperature Unit	C
14	123	MNvit	TX	A1	ST+S9_C0	14	HUMID	Atmospheric Relative Humidity Percent	50
15	123	MNvit	TX	A1	ST+S9_C0	15	ATMCO2	Atmospheric CO2 Percent	5
16	123	MNvit	TX	A1	ST+S9_C0	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
17	123	MNvit	TX	A1	ST+S9_C0	17	EXPTYP	Exposure Type	Submerged
18	123	MNvit	TX	A1	ST+S9_C0	18	SAMTYP	Sample Type	Total Particulate Matter in DMSO
19	123	MNvit	TX	A1	ST+S9_C0	19	INTRVN	Name of the Intervention Article	Tobacco ProdA
20	123	MNvit	TX	A1	ST+S9_C0	20	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Negative Control
21	123	MNvit	TX	A1	ST+S9_C0	21	ITVCONC	Concentration of intervention article	0
22	123	MNvit	TX	A1	ST+S9_C0	22	ITVCONCU	Concentration Unit	ug/ml
23	123	MNvit	TX	A1	ST+S9_C0	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
24	123	MNvit	TX	A1	ST+S9_C0	24	DUREFID	Smoke Regimen	Medium Intensity Regimen
25	123	MNvit	TX	A2 (table 1, row 2, ST exposure with S9 at concentration 1250)	ST+S9_C1250	1	TESTSYS	Test system	TK6 Lymphoblastoid Suspension Cells
26	123	MNvit	TX	A2	ST+S9_C1250	2	METACT	Metabolic Activation (this is the type of activation used)	+S9
27	123	MNvit	TX	A2	ST+S9_C1250	3	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
28	123	MNvit	TX	A2	ST+S9_C1250	4	TRTDMIN	Treatment Duration Minimum	3
29	123	MNvit	TX	A2	ST+S9_C1250	5	TRTDTRG	Treatment Duration Target	3.5
30	123	MNvit	TX	A2	ST+S9_C1250	6	TRTDMAX	Treatment Duration Maximum	4
31	123	MNvit	TX	A2	ST+S9_C1250	7	TRTDU	Treatment Duration Unit	HOURS
32	123	MNvit	TX	A2	ST+S9_C1250	8	RCVDMIN	Recovery Duration Minimum	23.5
33	123	MNvit	TX	A2	ST+S9_C1250	9	RCVDTRG	Recovery Duration Target	24
34	123	MNvit	TX	A2	ST+S9_C1250	10	RCVDMAX	Recovery Duration Maximum	24.5
35	123	MNvit	TX	A2	ST+S9_C1250	11	RCVDU	Recovery Duration Unit	HOURS
36	123	MNvit	TX	A2	ST+S9_C1250	12	INCBTMP	Incubation Temperature	37
37	123	MNvit	TX	A2	ST+S9_C1250	13	INCBTMPU	Incubation Temperature Unit	C
38	123	MNvit	TX	A2	ST+S9_C1250	14	HUMID	Atmospheric Relative Humidity Percent	50
39	123	MNvit	TX	A2	ST+S9_C1250	15	ATMCO2	Atmospheric CO2 Percent	5
40	123	MNvit	TX	A2	ST+S9_C1250	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
41	123	MNvit	TX	A2	ST+S9_C1250	17	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
42	123	MNvit	TX	A2	ST+S9_C1250	18	SAMTYP	Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical)	Total Particulate Matter in DMSO
43	123	MNvit	TX	A2	ST+S9_C1250	19	INTRVN	Name of the Intervention Article	Tobacco ProdA
44	123	MNvit	TX	A2	ST+S9_C1250	20	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
45	123	MNvit	TX	A2	ST+S9_C1250	21	ITVCONC	Concentration of intervention article	1250
46	123	MNvit	TX	A2	ST+S9_C1250	22	ITVCONCU	Concentration Unit	ug/ml
47	123	MNvit	TX	A2	ST+S9_C1250	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
48	123	MNvit	TX	A2	ST+S9_C1250	24	DUREFID	Smoke Regimen	High Intensity Regimen

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