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title	tx.xpt (trial sets)

During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level

123

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-1-A (plate-col-row in the 96-well plate)	CSC-10 (through SLS-200)	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-1-A	CSC-10	WELLNUM (e.g., 1-A through 10-H)	Number representing the location of the well in the 96-well plate	1-A
3	123	NRU	TX	1-1-A	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
4	123	NRU	TX	1-1-A	CSC-10	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
5	123	NRU	TX	1-1-A	CSC-10	ITVCONC	intervention concentration	10
6	123	NRU	TX	1-1-A	CSC-10	ITVCONCU	intervention unit	ug/ml
	123	NRU		1		STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU		1		REGIME	Smoking Regime	Traditional combustible
	123	NRU		1		RUN	Assay run number (how is this different from REPNUM)	1
	123	NRU		1		PORT	Port ID	1
	123	NRU		1		SMPLID	Sample ID	030001
	123	NRU		1		SMKFRC	Smoke Fraction	A
	123	NRU		1		REPNUM	Replicate Number	1
11	123	NRU	TX	1-1-B	CSC-10	ITVCONC	intervention concentration	10
12	123	NRU	TX	1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	1-10-H	SLS-10	PLATENUM	Plate number	1
	123	NRU	TX	1-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	1-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	1-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	1-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	2-10-H	SLS-10	PLATENUM	Plate number	2
	123	NRU	TX	2-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	2-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	2-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	2-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	2-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml

2022-05-25

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MNvit

TX

A1

METACT

Metabolic Activation (should there be two parms? Presence, type)?

+S9

123

MNvit

TX

A1

TRTDRTRG

Treatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)

3

title	gt.xpt (similar to LB)

Image AddedImage Added

Row	STUDYID	ASSAYID	DOMAIN	TXCD	GTSEQ	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU
1	123	NRU	GT	1-1-A	1	RELABS	Relative Absorbance Reading	100	ug/ml	100	100	ug/ml
2	123	NRU	GT	1-1-B	1	RELABS	Relative Absorbance Reading	107	ug/ml	100	100	ug/ml
3	123	NRU	GT	1-1-C	1	RELABS	Relative Absorbance Reading	98.6	ug/ml	100	100	ug/ml
54	123	NRU	GT	1-1-D	1	RELABS	Relative Absorbance Reading	94.9	ug/ml	100	100	ug/ml
6	123	NRU	GT	1-1-E	1	RELABS	Relative Absorbance Reading	111
7	123	NRU	GT	1-1-F	1	RELABS	Relative Absorbance Reading	96.9
8	123	NRU	GT	1-1-G	1	RELABS	Relative Absorbance Reading	105
9	123	NRU	GT	1-1-H	1	RELABS	Relative Absorbance Reading	95.2
10	123	NRU	GT	1-2-A	1	RELABS	Relative Absorbance Reading	83.0
11	123	NRU	GT	1-2-B	1	RELABS	Relative Absorbance Reading	77.7
...				...
80	123	NRU	GT	1-10-H	1	RELABS	Relative Absorbance Reading	0.791
...				...
160	123	NRU	GT	2-10-H	1	RELABS	Relative Absorbance Reading	0.780

123

MNvit

TX

123

MNvit

TX

TRTDRTOL

Treatment Duration Tolerance

123

MNvit

TX

TRTDURU

Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

H

123

MNvit

TX

INTRVN

name of the intervention article

Bleomycin or Cyclophosphamid A

123

MNvit

TX

ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

123

MNvit

TX

A1

ITVCONC

Concentration of i a

0

123

MNvit

TX

A1

ITVCONCU

Concentration Unit

ug/ml

Expand

title	gt.xpt (similar to LB)

Image RemovedImage Removed

Row

STUDYID

ASSAYID

DOMAIN

TXCD

GTSEQ

GTTESTCD

GTTEST

GTCELLEV
(cells evaluated)

GTORRES

GTORRESU

GTSTRESC

GTSTRESN

GTSTRESU

GTDTC

GTNOMDY

GTELTM

GTTPTREF

1

123

NRU

GT

1-1-A

1

RELABS

Relative Absorbance Reading

100

ug/ml

100

ug/ml

2

123

NRU

GT

1-1-B

1

RELABS

Relative Absorbance Reading

107

ug/ml

100

ug/ml

3

123

NRU

GT

1-1-C

1

RELABS

Relative Absorbance Reading

98.6

ug/ml

100

ug/ml

54

123

NRU

GT

1-1-D

1

RELABS

Relative Absorbance Reading

94.9

ug/ml

100

ug/ml

6

123

NRU

GT

1-1-E

1

RELABS

Relative Absorbance Reading

111

7

123

NRU

GT

1-1-F

1

RELABS

Relative Absorbance Reading

96.9

8

123

NRU

GT

1-1-G

1

RELABS

Relative Absorbance Reading

105

9

123

NRU

GT

1-1-H

1

RELABS

Relative Absorbance Reading

95.2

10

123

NRU

GT

1-2-A

1

RELABS

Relative Absorbance Reading

83.0

11

123

NRU

GT

1-2-B

1

RELABS

Relative Absorbance Reading

77.7

...

80

123

NRU

GT

1-10-H

1

RELABS

Relative Absorbance Reading

0.791

...

160

123

NRU

GT

2-10-H

1

RELABS

Relative Absorbance Reading

0.780

1

123

MNvit

GT

A2

1

RICC

Relative Increase in Cell Count

134

15.7

%

15.7

%

2022-05-25

2

123

MNvit

GT

A2

2

RCC

Relative Cell Count

134

13.0

%

13.0

%

2022-05-25

3

123

MNvit

GT

A2

3

RPD

Relative Population Doubling

134

7.9

%

7.9

%

2022-05-25

4

123

MNvit

GT

A2

4

MNCELLS

Micronucleated Cells

3266

20

Cells

20

Cells

2022-05-25

5

123

MNvit

GT

A2

5

MNCELLS

Micronucleated Cells

2190

17

Cells

17

Cells

2022-05-25

6

123

MNvit

GT

A2

6

MNCELLS

Micronucleated Cells

2758

13

Cells

13

Cells

2022-05-25

7

123

MNvit

GT

A2

7

MNCELLS

Micronucleated Cells

2714

21

Cells

21

Cells

2022-05-25

8

123

MNvit

GT

A2

8

AVGREL

Average Relative MN Frequency

0.66

%

0.66

%

2022-05-25

9

123

MNvit

GT

A1

1

RICC

Relative Increase in Cell Count

154

0

%

0

%

2022-05-25

10

123

MNvit

GT

A1

2

RCC

Relative Cell Count

154

0

%

0

%

2022-05-25

11

123

MNvit

GT

A1

3

RPD

Relative Population Doubling

154

0

%

0

%

2022-05-25

12

123

MNvit

GT

A1

4

MNCELLS

Micronucleated Cells

3266

15

Cells

15

Cells

2022-05-25

13

123

MNvit

GT

A1

5

MNCELLS

Micronucleated Cells

2190

13

Cells

13

Cells

2022-05-25

14

123

MNvit

GT

A1

6

MNCELLS

Micronucleated Cells

2758

17

Cells

17

Cells

2022-05-25

15

123

MNvit

GT

A1

7

MNCELLS

Micronucleated Cells

2714

12

Cells

12

Cells

2022-05-25

16

123

MNvit

GT

A1

8

AVGREL

Average Relative MN Frequency

0.57

%

0.57

%

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Versions Compared

Old Version 9

New Version 10

Key

SET (what sponsor calls it)

(plate-col-row in the 96-well plate)

(through SLS-200)

PLATENUM. (e.g., 1 or 2)

WELLNUM (e.g., 1-A through 10-H)

(CT e.g, Product, positive control, negative control)