Page History

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Dataset wrap

Name	tx.xpt

Rowcaps

Rows 1-23:

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 24-46:

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	+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
16	123	MNvit	TX	A1	ST+S9_C0	17	EXPTYP	Exposure Type	Submerged
17	123	MNvit	TX	A1	ST+S9_C0	18	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	Smoke Regimen	Medium Intensity Regimen
24	123	MNvit	TX	A2	ST+S9_C1250	2	METACT	Metabolic Activation	+S9
25	123	MNvit	TX	A2	ST+S9_C1250	3	METACTFL	Y/N presence of metabolic 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	Submerged
40	123	MNvit	TX	A2	ST+S9_C1250	18	SAMTYP	Sample Type	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	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

Dataset wrap

Rows 16-18:

Rowcaps

Row 1:

Shows the value of REFID=

A

C0, This REFID refers to the trial set with a SETCD of '

SetA

A1', 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

5:	Show the values of

five

four observational units

0

C0_

1

Count1 through

0

C0_

5

Count4 that are within the parent experimental unit, REFID=

A

C0

Rows

12-14:

6:	Shows the value...
Row 7-10:	Show the values of four

Row 15:

Dataset2

tableid	relref.xpt

Row	STUDYID	GNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	MNvit	A!	C0		1	TRIAL SET
2	123	MNvit	A1	C0-

C1

Count1	C0	2	OBSERVATIONAL UNIT
3	123	MNvit	A!	C0-

C2

Count2	C0	2	OBSERVATIONAL UNIT
4	123	MNvit	A!	C0-

C3

Count3	C0	2	OBSERVATIONAL UNIT
5	123	MNvit	A1	C0-

C4

Count4	C0	2	OBSERVATIONAL UNIT
6	123	MNvit	A2	C1250	1	TRIAL SET
7	123	MNvit	A2	C1250-

C1

Count1	C1250	2	OBSERVATIONAL UNIT
8	123	MNvit	A2	C1250-

C2

Count2	C1250	2	OBSERVATIONAL UNIT
9	123	MNvit	A2	C1250-

C3

Count3	C1250	2	OBSERVATIONAL UNIT
10	123	MNvit	A2	C1250-

C4

Count4

C1250

2

OBSERVATIONAL UNIT

A1:

A2:

...

Dataset wrap

Name	gt.xpt

Rowcaps

Rows 1-5:	Show the number of revertant colonies per plate collected for each of five observational units ( REFID=0_1 through 0_5 as described in the relref dataset).
Rows 6, 7:	Show summary values collected (MEAN, STANDARD DEVIATION) for REFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the relref dataset.
Rows 8-13:	Revertent colonies were counted for each of three plates/observational units (REFID=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 REFID=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 (REFID=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 (REFID=18_1 through 18_3 as described in the relref dataset).
Rows 23-25:	Show summary values collected (MEAN, STANDARD DEVIATION, and FOLD INCREASE) for REFID=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	EUID	REFID	GTSEQ	GTTESTCD	GTTEST	GTCELLEV	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123	MNvit	GT	C0		1	RICC	Relative Increase in Cell Count	154	0	%	0	0	%	2022-05-25
2	123	MNvit	GT	C0		2	RCC	Relative Cell Count	154	0	%	0	0	%	2022-05-25
3	123	MNvit	GT	C0		3	RPD	Relative Population Doubling	154	0	%	0	0	%	2022-05-25
4	123	MNvit	GT	C0	C0-Count1	4	MNCELLS	Micronucleated Cells	2205	15	Cells	15	15	Cells	2022-05-25
5	123	MNvit	GT	C0	C0-Count2	5	MNCELLS	Micronucleated Cells	2474	13	Cells	13	13	Cells	2022-05-25
6	123	MNvit	GT	C0	C0-Count3	6	MNCELLS	Micronucleated Cells	2758	17	Cells	17	17	Cells	2022-05-25
7	123	MNvit	GT	C0	C0-Count4	7	MNCELLS	Micronucleated Cells	2669	12	Cells	12	12	Cells	2022-05-25
8	123	MNvit	GT	C0	C0	8	AVGREL	Average Relative MN Frequency		0.57	%	0.57	0.57	%	2022-05-25
9	123	MNvit	GT	C1250		1	RICC	Relative Increase in Cell Count	134	15.7	%	15.7	15.7	%	2022-05-25
10	123	MNvit	GT	C1250		2	RCC	Relative Cell Count	134	13.0	%	13.0	13.0	%	2022-05-25
11	123	MNvit	GT	C1250		3	RPD	Relative Population Doubling	134	7.9	%	7.9	7.9	%	2022-05-25
12	123	MNvit	GT	C1250	C1250-Count1	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
13	123	MNvit	GT	C1250	C1250-Count2	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
14	123	MNvit	GT	C1250	C1250-Count3	6	MNCELLS	Micronucleated Cells	2758	13	Cells	13	13	Cells	2022-05-25
15	123	MNvit	GT	C1250	C1250-Count4	7	MNCELLS	Micronucleated Cells	2714	21	Cells	21	21	Cells	2022-05-25
16	123	MNvit	GT	C1250	C1250	8	AVGREL	Average Relative MN Frequency		0.66	%	0.66	0.66	%	2022-05-25

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