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This is an example showing example shows a sample report table, trial design, and results data of Study #123 dataset for study 123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in using the in vitro Micronucleus Assaymicronucleus assay.

For the purposes of team review of the example data, the report is included in this section:

Sample data #1: Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay

Study info: This study was performed to assess the in vitro genotoxicity of 10 different tobacco products containing 1% to 2% nicotine. The genotoxic potential was determined using the in vitro micronucleus test with TK6 lymphoblastoid suspension cells. The study was conducted in compliance with the following documents:

OECD TG 487 (2010): Guideline for the testing of chemicals: In vitro mammalian cell micronucleus test.
BL SOP 132: Determination of the in vitro genotoxicity of condensates from tobacco products and ingredients for tobacco products / electronic vapour products – in vitro micronucleus test (IVM) with TK6 cells.

The cells were exposed to increasing dose levels of tobacco product using short term treatment in the presence and absence of an external metabolic activation system (ST+/-S9 mix) as well as a long term treatment in the absence of an external metabolic activation system (LT-S9 mix).

Toxicity was calculated as relative increase in cell count (RICC), relative cell count (RCC) and relative population doubling (RPD). RPD is the cytotoxicity measure used for the assessment. RICC and RCC are also reported but not considered for the assessment.

Note: OECD GUIDELINE FOR THE TESTING OF CHEMICALS

Population Doubling = [log (Post-treatment cell number ÷ Initial cell number)] ÷ log 2

Conclusion: All tobacco product evaluated did not induce any signs of severe toxicity or genotoxicity in any of the treatments and do not fulfil the criteria to be classified as genotoxic.

Reported results: (only listed the result of one tobacco product as an example)

Statistical analysis

Adjusted p-values calculated for the micronucleus frequencies for every dose level as compared to the corresponding solvent control after ST in the presence and absence of S9 mix as well as LT in the absence of S9 mix. One way ANOVA with posthoc Dunnett’s test for multiple comparisons for the dose response and a two tailed unpaired student’s t-test for the comparison of positive and negative control were used. The difference between the samples is considered statistically significant at p≤0.05.

Treatment

Test date

Concentration [µg/ml]

Adjusted p- value

ST+ S9

25.05.2022

ST-S9

25.05.2022

LT-S9

25.05.2022

Bleo: Bleomycin; CPA: Cyclophosphamid A; statistically significant increases are highlighted in bold.

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title	Study 123, Report (for reference only, will be deleted?)

Fold increase of MN

over background

Significant increase Y/N

1250

0.9

0.9973

N

2500

0.9

0.9517

N

3750

0.6

0.2654

N

5000

0.9

0.9895

N

CPA [5µg/ml]

3.1

0.0003

Y

1250

1.6

0.6408

N

2500

1.3

0.8995

N

3750

2.9

0.0106

N

5000

1.0

> 0.9999

N

Bleo [0.2µg/ml]

3.8

0.0002

Y

1250

0.7

0.5958

N

2500

1.3

0.6378

N

3750

0.5

0.1146

N

5000

1.1

0.9929

N

Bleo [0.5µg/ml]

2.9

0.0047

Y

Expand

title	Study 123, Raw data (for reference only, will be deleted?)

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Sample Report Table for Study 123

Image Added

Dataset wrap

Rowcaps

Rows 1-2:	Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant's study reference ID is not applicable.
Rows 10-13:	Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The study director is associated with the test facility.
Rows 14-16:	Show that TSGRPID (TSGRPID=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Mammalian Cell Micronucleus Assay.
Rows 19-20:	Show that the species is human and the cell line is TK6 lymphoblastoid in this study.

Dataset2

Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	TS	1		GLPFL	GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2022-05-25
5	123	TS	1		STITLE	Study Title	Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
6	123	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7	123	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
8	123	TS	1		APPLCNT	Applicant	Example Applicant, Inc.
9	123	TS	1		APREFID	Study Reference ID		NOT APPLICABLE
10	123	TS	1	1	TSTFNAM	Test Facility Name	Example Test Lab Name
11	123	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
12	123	TS	1	1	TFCNTRY	Test Facility Country	USA
13	123	TS	1	1	STDIR	Study Director	Dr. R. Smith
14	123	TS	1	2	TSTGDNAM	Testing Guideline Name	GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15	123	TS	1	2	TSTGDORG	Testing Guideline Organization	OECD
16	123	TS	1	2	TSTGDVER	Testing Guideline Version	29-July-2016
17	123	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
18	123	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	MNvit
19	123	TS	1		SPECIES	Species	HUMAN
20	123	TS	1		CELLLN	Cell Line	TK6 LYMPHOBLASTOID

This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.

Dataset wrap

Name	tx

Rowcaps

Rows 1-23:

Show trial set parameters and 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 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	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	A1	ST+S9_C0	1	MTACTIND	Metabolic Activating Agent Name	+S9
2	123	TX	A1	ST+S9_C0	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123	TX	A1	ST+S9_C0	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	TX	A1	ST+S9_C0	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123	TX	A1	ST+S9_C0	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123	TX	A1	ST+S9_C0	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	TX	A1	ST+S9_C0	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	TX	A1	ST+S9_C0	8	RCVDTRG	Recovery Duration Target	24
9	123	TX	A1	ST+S9_C0	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	TX	A1	ST+S9_C0	10	RCVDU	Recovery Duration Unit	HOURS
11	123	TX	A1	ST+S9_C0	11	INCBTMP	Incubation Temperature	37
12	123	TX	A1	ST+S9_C0	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A1	ST+S9_C0	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	TX	A1	ST+S9_C0	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A1	ST+S9_C0	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	TX	A1	ST+S9_C0	16	EXPTYP	Exposure Type	Submerged
17	123	TX	A1	ST+S9_C0	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	TX	A1	ST+S9_CO	18	ITVNAM	Intervention Article Name	Tobacco ProdA
19	123	TX	A1	ST+S9_C0	19	ITVTYPE	Intervention Article Type	Negative Control
20	123	TX	A1	ST+S9_C0	20	ITVCONC	Intervention Article Concentration	0
21	123	TX	A1	ST+S9_C0	21	ITVCONCU	Intervention Article Concentration Unit	ug/ml
22	123	TX	A1	ST+S9_C0	22	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
23	123	TX	A1	ST+S9_C0	23	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24	123	TX	A2	ST+S9_C1250	24	MTACTIND	Metabolic Activating Agent Name	+S9
25	123	TX	A2	ST+S9_C1250	25	METACTFL	Presence of Metabolic Activation Flag	Y
26	123	TX	A2	ST+S9_C1250	26	IVTDMIN	In vitro Treatment Duration Minimum	3
27	123	TX	A2	ST+S9_C1250	27	IVTDTRG	In vitro Treatment Duration Target	3.5
28	123	TX	A2	ST+S9_C1250	28	IVTDMAX	In vitro Treatment Duration Maximum	4
29	123	TX	A2	ST+S9_C1250	29	IVTDU	In vitro Treatment Duration Unit	HOURS
30	123	TX	A2	ST+S9_C1250	30	RCVDMIN	Recovery Duration Minimum	23.5
31	123	TX	A2	ST+S9_C1250	31	RCVDTRG	Recovery Duration Target	24
32	123	TX	A2	ST+S9_C1250	32	RCVDMAX	Recovery Duration Maximum	24.5
33	123	TX	A2	ST+S9_C1250	33	RCVDU	Recovery Duration Unit	HOURS
34	123	TX	A2	ST+S9_C1250	34	INCBTMP	Incubation Temperature	37
35	123	TX	A2	ST+S9_C1250	35	INCBTMPU	Incubation Temperature Unit	C
36	123	TX	A2	ST+S9_C1250	36	ATMRHP	Atmospheric Relative Humidity Percent	50
37	123	TX	A2	ST+S9_C1250	37	ATMCO2P	Atmospheric CO2 Percent	5
38	123	TX	A2	ST+S9_C1250	38	SPTOBID	Applicant-defined tobacco identifier	CIG01a
39	123	TX	A2	ST+S9_C1250	39	EXPTYP	Exposure Type	Submerged
40	123	TX	A2	ST+S9_C1250	40	SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123	TX	A2	ST+S9_C1250	41	ITVNAM	Intervention Article Name	Tobacco ProdA
42	123	TX	A2	ST+S9_C1250	42	ITVTYPE	Intervention Article Type	Product
43	123	TX	A2	ST+S9_C1250	43	ITVCONC	Intervention Article Concentration	1250
44	123	TX	A2	ST+S9_C1250	44	ITVCONCU	Intervention Article Concentration Unit	ug/ml
45	123	TX	A2	ST+S9_C1250	45	SPDEVID	Applicant-defined Device Identifier	PUFFMASTER2023
46	123	TX	A2	ST+S9_C1250	46	SMKRGM	Smoking Regimen	HIGH INTENSITY REGIMEN

Dataset wrap

Name	relref

Rowcaps

Row 1:	Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of "A1", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 2-5:	Show the values of 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.
Row 6:	Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of "A2", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 7-10:	Show the values of 4 observational units (C1250_Count1 through C1250_Count4) that are within the parent experimental unit, REFID=C1250. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.

Dataset2

tableid	relref

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	A1	C0		1	EXPERIMENTAL UNIT/TRIAL SET
2	123	A1	C0-Count1	C0	2	OBSERVATIONAL UNIT
3	123	A1	C0-Count2	C0	2	OBSERVATIONAL UNIT
4	123	A1	C0-Count3	C0	2	OBSERVATIONAL UNIT
5	123	A1	C0-Count4	C0	2	OBSERVATIONAL UNIT
6	123	A2	C1250		1	EXPERIMENTAL UNIT/TRIAL SET
7	123	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT
8	123	A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9	123	A2	C1250-Count3	C1250	2	OBSERVATIONAL UNIT
10	123	A2	C1250-Count4	C1250	2	OBSERVATIONAL UNIT

Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
Assumption: A Trial (study) can have more than one assay type
Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
Assumption: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt) - we can discuss if this should be in TS when there is only one device for a study
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)

(This is a copy from the SDTM Example. Cigarette Design Parameters, will need scription team)

Dataset wrap

Name	gt

Rowcaps

Rows 1-3, 8:	Show percentage result values that apply to GTREFID=C0. REFID=C0, as shown in the RELREF dataset, relates this data to the trial set in the first row of table 1 in the sample report table for study 123.
Rows 4-7:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
Rows 9-11, 16:	Show percentage result values that apply to GTREFID=C1250. REFID=C1250, as shown in the RELREF dataset, relates this data to the trial set in the second row of table 1 in the sample report table for study 123.
Rows 12-15:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.

Dataset2

Row	STUDYID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTCELLEV	GTORRES	GTORRESU	GTCOLSRT

Expand

title	ts.xpt (trial summary, study level parameters)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

123

MNvit

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

2

123

MNvit

TS

2

GLPTYP

Good Laboratory Practice Type

OECD

3

123

MNvit

TS

1

STSTDTC

Study Start Date

2022-05-25

4

123

MNvit

TS

1

STITLE

Study Title

Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay

5

123

MNvit

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6

123

MNvit

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7

123

MNvit

TS

1

SSPONSOR

Sponsor Organization

Example Sponsor Inc.

8

123

MNvit

TS

1

SPREFID

Sponsor's Study Reference ID

NOT APPLICABLE

9

123

MNvit

TS

1

TSTFNAM

Test Facility Name

Example Tox Lab Name

10

123

MNvit

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11

123

MNvit

TS

1

TFCNTRY

Test Facility Country

USA

12

123

MNvit

TS

1

STDIR

Study Director

Dr. R. Smith

13

123

MNvit

TS

1

GLPFL

GLP Flag

Y

14

123

MNvit

TS

1

ASTD

Assay Standard

OECD Test No. 487

15

123

MNvit

TS

1

ASTDV

Assay Standard Version

2016-07-29

16

123

MNvit

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

17

123

MNvit

TS

1

SSSTYP

Study Sub Type

In Vitro Micronucleus

18

123

MNvit

TS

1

SPECIES

Species

Homo Sapiens

19

123

MNvit

TS

1

TESTSYS

Test System

TK6 Lymphoblastoid Suspension Cells

Expand

title	to.xpt (tobacco identifiers, design paramters)

Rows 1-4:	Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS.
Rows 5-10:	Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR.

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	123	DI	PUFFMASTER3K	1	DEVTYPE	Device Type	ENDS
2	123	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme Machines
3	123	DI	PUFFMASTER3K	3	MODEL	Model Number	45-JFI
4	123	DI	PUFFMASTER3K	4	SERIAL	Serial Number	456789132-AXQ
5	123	DI	PUFFMASTER3K	5	FDAUDI	FDA Unique Device Identifier	456789123xyz
6	123	DI	PUFFMASTER2023	1	DEVTYPE	Device Type	SmokeMachine
7	123	DI	PUFFMASTER2023	2	MANUF	Manufacturer	Acme Machines
8	123	DI	PUFFMASTER2023	3	MODEL	Model Number	62-PLC
9	123	DI	PUFFMASTER2023	4	SERIAL	Serial Number	215964564-NFS
10	123	DI	UsualCTCigarette	1	DEVTYPE	Device Type	Combustible Tobacco Cigarette
11	123	DI	UsualCTCigarette	2	MANUF	Manufacturer	Philip Morris International
12	123	DI	UsualCTCigarette	3	MODEL	Model Number	Marlboro Red
13	123	DI	UsualCTCigarette	4	SERIAL	Serial Number	123456789

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