Page History

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Dataset wrap

Name	tx

Rowcaps

Rows 1-14:	Show trial set, SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species Salmonella Typhimurium.
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: Check row captions and other red font items (SET for Set STM). and added G data to GT. Add SetSTM anywhere else? (RELREF?)

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetSTM STM	SALMONELLA TYPHIMURIUM	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	2	TRTDMIN	Treatment Duration Minimum	71.5
3	8325064	Ames	TX	SetSTM A-TA98-C0	SALMONELLA TYPHIMURIUM	3	TRTDTRG	Treatment Duration Target	72
4	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	4	TRTDMAX	Treatment Duration Maximum	72.5
5	8325064	Ames	TX	SetSTM A-TA98-C0	SALMONELLA TYPHIMURIUM	5	TRTDU	Treatment Duration Unit	HOURS
6	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	6	INCBTMP	Incubation Temperature	37
7	8325064	Ames	TX	SetSTM A-TA98-C0	SALMONELLA TYPHIMURIUM	7	INCBTMPU	Incubation Temperature Unit	C
8	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	8	HUMID	Atmospheric Relative Humidity Percent	50
9	8325064	Ames	TX	SetSTM A-TA98-C0	SALMONELLA TYPHIMURIUM	9	ATMCO2	Atmospheric CO2 Percent	5
10	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
11	8325064	Ames	TX	SetSTM A-TA98-C0	SALMONELLA TYPHIMURIUM	11	EXPTYP	Exposure Type	Submerged
12	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	13	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
14	8325064	Ames	TX	SetSTMA-TA98-C0	SALMONELLA TYPHIMURIUM	14	DUREFID	Smoke Regimen	NON-INTENSE REGIMEN
15	8325064	Ames	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
16	8325064	Ames	TX	SetA	A-TA98-C0	16	METACT	Metabolic Activation	NOT APPLICABLE
17	8325064	Ames	TX	SetA	A-TA98-C0	17	METACTFL	Y/N presence of metabolic activation	N
18	8325064	Ames	TX	SetA	A-TA98-C0	18	INTRVN	Name of the intervention article	TA1
19	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVTYPE	Type of intervention article	Vehicle Control
20	8325064	Ames	TX	SetA	A-TA98-C0	20	ITVCONC	Concentration of intervention article	0
21	8325064	Ames	TX	SetA	A-TA98-C0	21	ITVCONCU	Concentration Unit	ug/plate
22	8325064	Ames	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
23	8325064	Ames	TX	SetF	F-TA98-C500	23	STRAIN	Strain/Substrain	TA98
24	8325064	Ames	TX	SetF	F-TA98-C500	24	METACT	Metabolic Activation	NOT APPLICABLE
25	8325064	Ames	TX	SetF	F-TA98-C500	25	METACTFL	Y/N presence of metabolic activation	N
26	8325064	Ames	TX	SetF	F-TA98-C500	26	INTRVN	Name of the intervention article	TA1
27	8325064	Ames	TX	SetF	F-TA98-C500	27	ITVTYPE	Type of intervention article	Product
28	8325064	Ames	TX	SetF	F-TA98-C500	28	ITVCONC	Concentration of intervention article	500
29	8325064	Ames	TX	SetF	F-TA98-C500	29	ITVCONCU	Concentration Unit	ug/plate
30	8325064	Ames	TX	SetF	F-TA98-C500	30	TRTV	Treatment Vehicle	DMSO
31	8325064	Ames	TX	SetG	G-TA98-C1600	31	STRAIN	Strain/Substrain	TA98
32	8325064	Ames	TX	SetG	G-TA98-C1600	32	METACT	Metabolic Activation	NOT APPLICABLE
33	8325064	Ames	TX	SetG	G-TA98-C1600	33	METACTFL	Y/N presence of metabolic activation	N
34	8325064	Ames	TX	SetG	G-TA98-C1600	34	INTRVN	Name of the intervention article	TA1
35	8325064	Ames	TX	SetG	G-TA98-C1600	35	ITVTYPE	Type of intervention article	Product
36	8325064	Ames	TX	SetG	G-TA98-C1600	36	ITVCONC	Concentration of intervention article	1600
37	8325064	Ames	TX	SetG	G-TA98-C1600	37	ITVCONCU	Concentration Unit	ug/plate
38	8325064	Ames	TX	SetG	G-TA98-C1600	38	TRTV	Treatment Vehicle	DMSO
39	8325064	Ames	TX	SetR	R-TA100-C2	39	STRAIN	Strain/Substrain	TA100
40	8325064	Ames	TX	SetR	R-TA100-C2	40	METACT	Metabolic Activation	NOT APPLICABLE
41	8325064	Ames	TX	SetR	R-TA100-C2	41	METACTFL	Y/N presence of metabolic activation	N
42	8325064	Ames	TX	SetR	R-TA100-C2	42	INTRVN	name of the intervention article	NaN3
43	8325064	Ames	TX	SetR	R-TA100-C2	43	ITVTYPE	type of intervention article	Positive Control
44	8325064	Ames	TX	SetR	R-TA100-C2	44	ITVCONC	Concentration of intervention article	2
45	8325064	Ames	TX	SetR	R-TA100-C2	45	ITVCONCU	Concentration Unit	ug/plate
46	8325064	Ames	TX	SetR	R-TA100-C2	46	TRTV	Treatment Vehicle	DMSO

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Dataset wrap

Name	relref

Rowcaps

Row 1:	Shows the value of REFID=A, This REFID refers to the trial set with a SETCD of 'SetA', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 2-6:	Show the values of five observational units 0_1 through 0_5 that are within the parent experimental unit, REFID=A
Row 7:	Shows the value of REFID=F, This REFID refers to the trial set with a SETCD of 'SetF', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 8-10:	Show the values of three observational units 6_1 through 6_3 that are within the parent experimental unit, REFID=F
Row 11:	Shows the value of REFID=G, This REFID refers to the trial set with a SETCD of 'SetG', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 12-14:	Show the values of three observational units 7_1 through 7_3 that are within the parent experimental unit, REFID=F
Row 15:	Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of 'SetG', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 16-18:	Show the values of three observational units 18_1 through 18_3 that are within the parent experimental unit, REFID=F

Dataset2

tableid	relref.xpt

Row	STUDYID	GNTXAID	SETCD	REFID	PARENT	LEVELLVLDESC	LVLDESC
	8325064	Ames	SetSTM	STM		1	TRIAL SET
1	8325064	Ames	SetA	A	STM	12	TRIAL SET
2	8325064	Ames	SetA	01_1	A	23	OBSERVATIONAL UNIT
3	8325064	Ames	SetA	01_2	A	23	OBSERVATIONAL UNIT
4	8325064	Ames	SetA	01_3	A	23	OBSERVATIONAL UNIT
5	8325064	Ames	SetA	01_4	A	23	OBSERVATIONAL UNIT
6	8325064	Ames	SetA	01_5	A	23	OBSERVATIONAL UNIT
7	8325064	Ames	SetF	F	STM	12	TRIAL SET
8	8325064	Ames	SetF	6_1	F	23	OBSERVATIONAL UNIT
9	8325064	Ames	SetF	6_2	F	23	OBSERVATIONAL UNIT
10	8325064	Ames	SetF	6_3	F	23	OBSERVATIONAL UNIT
11	8325064	Ames	SetG	G	STM	21	TRIAL SET
12	8325064	Ames	SetG	7_1	G	23	OBSERVATIONAL UNIT
13	8325064	Ames	SetG	7_2	G	23	OBSERVATIONAL UNIT
14	8325064	Ames	SetG	7_3	G	23	OBSERVATIONAL UNIT
15	8325064	Ames	SetG	R	STM	21	TRIAL SET
16	8325064	Ames	SetR	18_1	R	23	OBSERVATIONAL UNIT
17	8325064	Ames	SetR	18_2	R	23	OBSERVATIONAL UNIT
18	8325064	Ames	SetR	18_3	R	23	OBSERVATIONAL UNIT

Dataset wrap

Name	gt

Rowcaps

Rows 1-5:	Show the number of revertant colonies per plate collected for each of five observational units GTREFID=0_1 through 0_5 (see description in the relref dataset).
Rows 6, 7:	Show summary values collected (MEAN, STANDARD DEVIATION) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the relref dataset.
Rows 8-13:	Revertent colonies were counted for each of three plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" = "Very thin background bacterial lawn"
Rows 14-16:	Show summary values collected (MEAN, STANDARD DEVIATION, and FOLD INCREASE) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the relref dataset.
Rows 17-19:	Show three plates/observational units (GTREFID=5_1 through 5_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T".
Rows 20-22:	Show the number of revertant colonies per plate collected for each of three observational units (GTREFID=18_1 through 18_3).
Rows 23-25:	Show summary values collected (MEAN, STANDARD DEVIATION, and FOLD INCREASE) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the relref dataset.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTSTAT	GTREASND	GTMETHOD	GTDTC
1	8325064	Ames	GT	1	01_1	RPP	Revertant Colony Numbers Per Plate	26	NOT APPLICABLE		26	26	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
2	8325064	Ames	GT	2	01_2	RPP	Revertant Colony Numbers Per Plate	35	NOT APPLICABLE		35	35	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
3	8325064	Ames	GT	3	01_3	RPP	Revertant Colony Numbers Per Plate	39	NOT APPLICABLE		39	39	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
4	8325064	Ames	GT	4	01_4	RPP	Revertant Colony Numbers Per Plate	35	NOT APPLICABLE		35	35	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
5	8325064	Ames	GT	5	01_5	RPP	Revertant Colony Numbers Per Plate	30	NOT APPLICABLE		30	30	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
6	8325064	Ames	GT	6	A	RPP	Revertant Colony Numbers Per Plate	33.0	NOT APPLICABLE	MEAN	33.0	33.0	NOT APPLICABLE				2015-08-03
7	8325064	Ames	GT	7	A	RPP	Revertant Colony Numbers Per Plate	5.0	NOT APPLICABLE	STANDARD DEVIATION	5.0	5.0	NOT APPLICABLE				2015-08-03
8	8325064	Ames	GT	1	6_1	RPP	Revertant Colony Numbers Per Plate	8	NOT APPLICABLE		8	8	NOT APPLICABLE			MANUALLY COUNTED	2015-08-03
9	8325064	Ames	GT	2	6_1	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
10	8325064	Ames	GT	3	6_2	RPP	Revertant Colony Numbers Per Plate	10	NOT APPLICABLE		10	10	NOT APPLICABLE			MANUALLY COUNTED	2015-08-03
11	8325064	Ames	GT	4	6_2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
12	8325064	Ames	GT	5	6_3	RPP	Revertant Colony Numbers Per Plate	12	NOT APPLICABLE		12	12	NOT APPLICABLE			MANUALLY COUNTED	2015-08-03
13	8325064	Ames	GT	6	6_3	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
14	8325064	Ames	GT	7	F	RPPMEAN	Mean Rev Colony Num Per Plate	10.0	NOT APPLICABLE	MEAN	10.0	10.0	NOT APPLICABLE				2015-08-03
15	8325064	Ames	GT	8	F	RPPSTDDV	Std Dev Rev Colony Num Per Plate	2.0	NOT APPLICABLE	STANDARD DEVIATION	2.0	2.0	NOT APPLICABLE				2015-08-03
16	8325064	Ames	GT	9	F	RPPFLDIC	Fold Increase Rev Colony Num Per Plate	0.3	NOT APPLICABLE	FOLD INCREASE	0.3	0.3	NOT APPLICABLE				2015-08-03
17	8325064	Ames	GT	1	57_1	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
18	8325064	Ames	GT	2	57_2	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
19	8325064	Ames	GT	3	57_3	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
20	8325064	Ames	GT	1	18_1	RPP	Revertant Colony Numbers Per Plate	812	NOT APPLICABLE		812	812	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
21	8325064	Ames	GT	2	18_2	RPP	Revertant Colony Numbers Per Plate	912	NOT APPLICABLE		912	912	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
22	8325064	Ames	GT	3	18_3	RPP	Revertant Colony Numbers Per Plate	839	NOT APPLICABLE		839	839	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
23	8325064	Ames	GT	4	R	RPPMEAN	Mean Rev Colony Num Per Plate	854.3	NOT APPLICABLE	MEAN	854.3	854.3	NOT APPLICABLE				2015-08-03
24	8325064	Ames	GT	5	R	RPPSTDDV	Std Dev Rev Colony Num Per Plate	51.7	NOT APPLICABLE	STANDARD DEVIATION	51.7	51.7	NOT APPLICABLE				2015-08-03
25	8325064	Ames	GT	6	R	RPPFLDIC	Fold Increase Rev Colony Num Per Plate	6.4	NOT APPLICABLE	FOLD INCREASE	6.4	6.4	NOT APPLICABLE				2015-08-03

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