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Dataset wrap

Name	tx

Rowcaps

Rows 1-14:	Show trial set, SetSTM,
Rows 1-22:	Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.
Rows 23-44:	Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the vehicle control (i.e., Strain of TA100, positive control with a concentration value of 2). SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Rows 13, 35:	Show a value for SPTOBID=CIG01a. SPTOBID is Sponsor-Defined Tobacco Product ID that is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2 Product Design Parameters and Conformance Testing Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in the Section 2.8.8.1 Tobacco Product Identifiers and Descriptors (TO).
Rows 21, 43:	Show a value for SPDEVID. SPDEVID is the Sponsor defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset. The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the di.xpt in SDTM Example.Product HPHC ENDS Testing. The DI domain is described in the Section 2.8.9.7 Device Identifiers (DI).
Rows 22, 44:	Show a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the du.xpt in SDTM Example.Product HPHC ENDS Testing. The DU domain is described in the Section 2.8.9.8 Device-In-Use (DU).

Dataset2

Aug 23: LAK add F & G to TX and add G data to GT.

NON-INTENSE REGIMEN

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetASetSTM	A-TA98-C0	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	Ames	TX	SetASetSTM	A-TA98-C0	2	STRAIN	Strain/Substrain	TRTDMIN	Treatment Duration Minimum	71.5TA98
3	8325064	Ames	TX	SetASetSTM	A-TA98-C0	3	METACT	Metabolic Activation	TRTDTRG	Treatment Duration Target	72NOT APPLICABLE
4	8325064	Ames	TX	SetASetSTM	A-TA98-C0	4	METACTFL	Y/N presence of metabolic activation	TRTDMAX	Treatment Duration Maximum	72.5N
5	8325064	Ames	TX	SetA SetSTM	A-TA98-C0	5	TRTDMINTRTDU	Treatment Duration MinimumUnit	71.5HOURS
6	8325064	Ames	TX	SetASetSTM	A-TA98-C0	6	TRTDTRG	Treatment Duration Target	INCBTMP	Incubation Temperature	3772
7	8325064	Ames	TX	SetA SetSTM	A-TA98-C0	7	TRTDMAX	Treatment Duration Maximum	INCBTMPU	Incubation Temperature Unit	C72.5
8	8325064	Ames	TX	SetASetSTM	A-TA98-C0	8	TRTDU	Treatment Duration Unit	HUMID	Atmospheric Relative Humidity Percent	50HOURS
9	8325064	Ames	TX	SetA SetSTM	A-TA98-C0	9	INCBTMP	Incubation Temperature	ATMCO2	Atmospheric CO2 Percent	537
10	8325064	Ames	TX	SetASetSTM	A-TA98-C0	10	INCBTMPU	Incubation Temperature Unit	SPTOBID	Sponsor defined tobacco identifier	CIG01aC
11	8325064	Ames	TX	SetA SetSTM	A-TA98-C0	11	HUMID	Atmospheric Relative Humidity Percent	EXPTYP	Exposure Type	Submerged50
12	8325064	Ames	TX	SetASetSTM	A-TA98-C0	12	ATMCO2	Atmospheric CO2 Percent	SAMTYP	Sample Type	Total Particulate Matter in PBS5
13	8325064	Ames	TX	SetASetSTM	A-TA98-C0	13	SPTOBIDSPDEVID	Sponsor defined tobacco device identifier	CIG01aPUFFMASTER3K
14	8325064	Ames	TX	SetASetSTM	A-TA98-C0	14	EXPTYPDUREFID	Exposure Type	Smoke Regimen	NON-INTENSE REGIMENSubmerged
15	8325064	Ames	TX	SetA	A-TA98-C0	15	SAMTYP	Sample Type	STRAIN	Strain/Substrain	TA98Total Particulate Matter in PBS
16	8325064	Ames	TX	SetA	A-TA98-C0	16	INTRVN	Name of the intervention article	METACT	Metabolic Activation	NOT APPLICABLETA1
17	8325064	Ames	TX	SetA	A-TA98-C0	17	ITVTYPE	Type of intervention article	METACTFL	Y/N presence of metabolic activation	NVehicle Control
18	8325064	Ames	TX	SetA	A-TA98-C0	18	ITVCONCINTRVN	Concentration Name of the intervention article	0TA1
19	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVCONCU	Concentration Unit	ITVTYPE	Type of intervention article	Vehicle Controlug/plate
20	8325064	Ames	TX	SetA	A-TA98-C0	20	TRTV	Treatment Vehicle	ITVCONC	Concentration of intervention article	0DMSO
21	8325064	Ames	TX	SetA	A-TA98-C0	21	SPDEVID	Sponsor defined device identifier	ITVCONCU	Concentration Unit	ug/platePUFFMASTER3K
22	8325064	Ames	TX	SetA	A-TA98-C0	22	DUREFIDTRTV	Smoke Regimen	Treatment Vehicle	DMSONON-INTENSE REGIMEN
23	8325064	Ames	TX	SetF	F-TA98-C500	23	SPECIESSTRAIN	Species	Strain/Substrain	TA98SALMONELLA TYPHIMURIUM
24	8325064	Ames	TX	SetF	F-TA98-C500	24	STRAIN	Strain/Substrain	METACT	Metabolic Activation	NOT APPLICABLETA98
25	8325064	Ames	TX	SetF	F-TA98-C500	25	METACT	Metabolic Activation	METACTFL	Y/N presence of metabolic activation	NNOT APPLICABLE
26	8325064	Ames	TX	SetF	F-TA98-C500	26	METACTFL	Y/N presence of metabolic activation	INTRVN	Name of the intervention article	TA1N
27	8325064	Ames	TX	SetF	F-TA98-C500	27	TRTDMIN	Treatment Duration Minimum	ITVTYPE	Type of intervention article	Product71.5
28	8325064	Ames	TX	SetF	F-TA98-C500	28	TRTDTRG	Treatment Duration Target	ITVCONC	Concentration of intervention article	50072
29	8325064	Ames	TX	SetF	F-TA98-C500	29	TRTDMAX	Treatment Duration Maximum	ITVCONCU	Concentration Unit	ug/plate72.5
30	8325064	Ames	TX	SetF	F-TA98-C500	30	TRTDUTRTV	Treatment Duration UnitVehicle	HOURSDMSO
31	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	31	INCBTMP	Incubation Temperature	STRAIN	Strain/Substrain	TA9837
32	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	32	INCBTMPU	Incubation Temperature Unit	METACT	Metabolic Activation	NOT APPLICABLEC
33	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	33	HUMID	Atmospheric Relative Humidity Percent	METACTFL	Y/N presence of metabolic activation	N50
34	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	34	ATMCO2	Atmospheric CO2 Percent	INTRVN	Name of the intervention article	TA15
35	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	35	SPTOBID	Sponsor defined tobacco identifier	ITVTYPE	Type of intervention article	ProductCIG01a
36	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	36	EXPTYP	Exposure Type	ITVCONC	Concentration of intervention article	1600Submerged
37	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	37	SAMTYPITVCONCU	Sample Type	Concentration Unit	ug/plateTotal Particulate Matter in PBS
38	8325064	Ames	TX	SetFSetG	FG-TA98-C500C1600	38	INTRVN	Name of the intervention article	TRTV	Treatment Vehicle	DMSOTA1
39	8325064	Ames	TX	SetF SetR	FR-TA98TA100-C500C2	39	ITVTYPE	Type of intervention article	STRAIN	Strain/Substrain	TA100Vehicle Control
40	8325064	Ames	TX	SetF SetR	FR-TA98TA100-C500	40	ITVCONC	Concentration of intervention article	500
41	8325064	Ames	TX	SetF	F-TA98-C500	41	ITVCONCU	Concentration Unit	ug/plate
42	8325064	Ames	TX	SetF	F-TA98-C500	42	TRTV	Treatment Vehicle	DMSO
43	8325064	Ames	TX	SetF	F-TA98-C500	43	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
44	8325064	Ames	TX	SetF	F-TA98-C500	44	DUREFID	Smoke Regimen	NON-INTENSE REGIMEN
45	8325064	Ames	TX	SetG	G-TA98-C1600	45	SPECIES	Species	SALMONELLA TYPHIMURIUM
46	8325064	Ames	TX	SetG	G-TA98-C1600	46	STRAIN	Strain/Substrain	TA98
47	8325064	Ames	TX	SetG	G-TA98-C1600	47	METACT	Metabolic Activation	NOT APPLICABLE
48	8325064	Ames	TX	SetG	G-TA98-C1600	48	METACTFL	Y/N presence of metabolic activation	N
49	8325064	Ames	TX	SetG	G-TA98-C1600	49	TRTDMIN	Treatment Duration Minimum	71.5
50	8325064	Ames	TX	SetG	G-TA98-C1600	50	TRTDTRG	Treatment Duration Target	72
51	8325064	Ames	TX	SetG	G-TA98-C1600	51	TRTDMAX	Treatment Duration Maximum	72.5
52	8325064	Ames	TX	SetG	G-TA98-C1600	52	TRTDU	Treatment Duration Unit	HOURS
53	8325064	Ames	TX	SetG	G-TA98-C1600	53	INCBTMP	Incubation Temperature	37
54	8325064	Ames	TX	SetG	G-TA98-C1600	54	INCBTMPU	Incubation Temperature Unit	C
C2	40	METACT	Metabolic Activation	NOT APPLICABLE
41	55	8325064	Ames	TX	SetG	G-TA98-C1600	HUMID	Atmospheric Relative Humidity Percent	50	56	8325064	Ames	TX	SetG	G-TA98-C1600	ATMCO2	Atmospheric CO2 Percent	5	57	8325064	Ames	TX	SetG	G-TA98-C1600	SPTOBID	Sponsor defined tobacco identifier	CIG01a	58	8325064	Ames	TX	SetG	G-TA98-C1600	EXPTYP	Exposure Type	Submerged	59	8325064	Ames	TX	SetG	G-TA98-C1600	SAMTYP	Sample Type	Total Particulate Matter in PBS	60	8325064	Ames	TX	SetG	G-TA98-C1600	INTRVN	Name of the intervention article	TA1	61	8325064	Ames	TX	SetG	G-TA98-C1600	ITVTYPE	Type of intervention article	Vehicle Control	62	8325064	Ames	TX	SetG	G-TA98-C1600	ITVCONC	Concentration of intervention article	1600	63	8325064	Ames	TX	SetG	G-TA98-C1600	ITVCONCU	Concentration Unit	ug/plate	64	8325064	Ames	TX	SetG	G-TA98-C1600	TRTV	Treatment Vehicle	DMSO	65	8325064	Ames	TX	SetG	G-TA98-C1600	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K	66	8325064	Ames	TX	SetG	G-TA98-C1600	DUREFID	Smoke Regimen	NON-INTENSE REGIMEN	67	8325064	Ames	TX	SetR	R-TA100-C2	SPECIES	Species	Salmonella typhimurium	68	8325064	Ames	TX	SetR	R-TA100-C2	STRAIN	Strain/Substrain	TA100	69	8325064	Ames	TX	SetR	R-TA100-C2	METACT	Metabolic Activation	NOT APPLICABLE	70	8325064	Ames	TX	SetR	R-TA100-C2	METACTFL	Y/N presence of metabolic activation	N	71	8325064	Ames	TX	SetR	R-TA100-C2	TRTDMIN	Treatment Duration Minimum	71.5	72	8325064	Ames	TX	SetR	R-TA100-C2	TRTDTRG	Treatment Duration Target	72	73	8325064	Ames	TX	SetR	R-TA100-C2	TRTDMAX	Treatment Duration Maximum	72.5	74	8325064	Ames	TX	SetR	R-TA100-C2	TRTDU	Treatment Duration Unit	HOURS	75	8325064	Ames	TX	SetR	R-TA100-C2	INCBTMP	Incubation Temperature	37	76	8325064	Ames	TX	SetR	R-TA100-C2	INCBTMPU	Incubation Temperature Unit	C	77	8325064	Ames	TX	SetR	R-TA100-C2	HUMID	Atmospheric Relative Humidity Percent	50	78	8325064	Ames	TX	SetR	R-TA100-C2	ATMCO2	Atmospheric CO2 Percent	5	79	8325064	Ames	TX	SetR	R-TA100-C2	41	METACTFL	Y/N presence of metabolic activation	N
42	SPTOBID	Sponsor defined tobacco identifier	CIG01a	80	8325064	Ames	TX	SetR	R-TA100-C2	EXPTYP	Exposure Type	Submerged	81	8325064	Ames	TX	SetR	R-TA100-C2	SAMTYP	Sample Type	Total Particulate Matter in PBS	82	8325064	Ames	TX	SetR	R-TA100-C2	42	INTRVN	name of the intervention article	TA1NaN3
8343	8325064	Ames	TX	SetR	R-TA100-C2	43	ITVTYPE	type of intervention article	Positive Control
8444	8325064	Ames	TX	SetR	R-TA100-C2	44	ITVCONC	Concentration of intervention article	2
8545	8325064	Ames	TX	SetR	R-TA100-C2	45	ITVCONCU	Concentration Unit	ug/plate
8646	8325064	Ames	TX	SetR	R-TA100-C2	46	TRTV	Treatment Vehicle	DMSO	87	8325064	Ames	TX	SetR	R-TA100-C2	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K	88	8325064	Ames	TX	SetR	R-TA100-C2	DUREFID	Smoke Regimen

REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified picture of an assay (below), the test tube that contains the possible mutagen is an example of an entity that would have a REFID indicating information at the level of trial set. The petri plate created from that test tube and used to count revertant numbers is an example of an entity that would be at an observational level.

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