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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.

Expand
titleSample Report Table for Study 123, Raw data (for reference only, will be deleted?)

ASSAYID
Dataset wrap
Expand
titlets.xpt (trial summary, study level parameters)
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

  • 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).  While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
    • 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)

Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
MNvit
TS1
GLPTYPGood Laboratory Practice TypeFDA
2123
MNvit
TS2
GLPTYPGood Laboratory Practice TypeOECD
3123
MNvit
TS1
STSTDTCStudy Start Date

GLPFLGLP FlagY
4123TS1
STSTDTCStudy Start Date2022-05-25
4

5123
MNvit
TS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential

of 10 tobacco products in the in vitro Micronucleus Assay

using the in vitro Neutral Red Uptake assay


6123
5123MNvit
TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6

7123
MNvit
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7

8123
MNvit
TS1
SSPONSOR

APPLCNT
Sponsor Organization

Applicant

Example
Sponsor
Applicant, Inc.
8

9123
MNvit
TS1
SPREFID

APREFID
Sponsor's
Study Reference ID
NOT APPLICABLE
9
10123
MNvit
TS11TSTFNAMTest Facility NameExample
Tox
Test Lab Name
10

11123
MNvit
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11

12123
MNvit
TS11TFCNTRYTest Facility CountryUSA
12

13123
MNvit
TS11STDIRStudy DirectorDr. R. Smith
13

14123
MNvit
TS12
GLPFLGLP FlagY14123
TSTGDNAMTesting Guideline NameGUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15123
MNvit
TS12
ASTDAssay Standard
TSTGDORGTesting Guideline OrganizationOECD
Test No. 487 
15

16123
MNvit
TS1
ASTDV
2TSTGDVERTesting Guideline
Assay Standard
Version
2016
29-
07
July-
29
2016
16

17123
MNvit
TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17

18123
MNvit
TS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus

GNTXAIDGenetic Toxicology Assay IdentifierMNvit
19123
18123MNvit
TS1
SPECIESSpecies
Homo Sapiens
HUMAN
20123TS1
CELLLNCell 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
Nametx
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
RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXA1ST+S9_C01MTACTINDMetabolic Activating Agent Name+S9
2123TXA1ST+S9_C02METACTFLPresence of Metabolic Activation FlagY
3123TXA1ST+S9_C03

IVTDMIN

In vitro Treatment Duration Minimum3
4123TXA1ST+S9_C04IVTDTRGIn vitro
Expand
titletx.xpt (trial sets)
  • Assumption:  SPDEVID (sponsor defined device identifier), and Test System  should be added at the trial set level (tx.xpt).  While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
    • 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)
  • 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).  While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
    • 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)

A1: Image Removed

A2:                                   Image Removed

RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNvitTX

A1

(table 1, row 1, ST exposure with S9)

ST+S9C01TESTSYSTest systemTK6 Lymphoblastoid Suspension Cells
2123MNvitTX

A1

ST+S9C02METACTMetabolic Activation  (this is the type of activation used)+S9
3123MNvitTXA1ST+S9C03METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y
4123MNvitTX

A1

ST+S9C04TRTDMINTreatment Duration Minimum3
5123MNvitTXA1ST+S9C05TRTDTRG
Treatment Duration Target3.5
6
5123
MNvit
TXA1ST+
S9C0
S9_C0
6
5
TRTDMAX
IVTDMAXIn vitro Treatment Duration Maximum4
7
6123
MNvit
TXA1ST+
S9C0
S9_C0
7
6
TRTDU
IVTDUIn vitro Treatment Duration UnitHOURS
8
7123
MNvit
TXA1ST+
S9C0
S9_C0
8
7RCVDMINRecovery Duration Minimum23.5
9
8123
MNvit
TXA1ST+
S9C0
S9_C0
9
8RCVDTRGRecovery Duration Target24
10
9123
MNvit
TXA1ST+
S9C0
S9_C0
10
9RCVDMAXRecovery Duration Maximum24.5
11
10123
MNvit
TXA1ST+
S9C0
S9_C0
11
10RCVDURecovery Duration UnitHOURS
12
11123
MNvit
TXA1ST+
S9C0
S9_C0
12
11INCBTMPIncubation Temperature37
13
12123
MNvit
TXA1ST+
S9C0
S9_C0
13
12INCBTMPUIncubation Temperature UnitC
14
13123
MNvit
TXA1ST+
S9C0
S9_C0
14
13
HUMID
ATMRHPAtmospheric Relative
Humidity 
Humidity Percent50
15
14123
MNvit
TXA1ST+
S9C0
S9_C0
15
14
ATMCO2
ATMCO2PAtmospheric CO2 Percent5
16
15123
MNvit
TXA1ST+
S9C0
S9_C0
16
15

SPTOBID

Sponsor

Applicant-defined tobacco identifier

CIG01a
17
16123
MNvit
TXA1ST+
S9C0
S9_C0
17
16EXPTYP

Exposure Type

 

Submerged
18
17123
MNvit
TXA1ST+
S9C0
S9_C0
18
17
SAMTYP 
SAMTYP

Sample Type

Total Particulate Matter in DMSO
19
18123
MNvit
TXA1ST+
S9C0
S9_CO
19
18
INTRVN
ITVNAM
Name of the

Intervention Article Name

Tobacco ProdA
20
19123
MNvit
TXA1ST+
S9C0
S9_C0
20choices of values:  product; negative control; positive control
19ITVTYPE

type of intervention article

Intervention Article Type

Negative Control
21
20123
MNvit
TXA1ST+
S9C0
S9_C0
21
20ITVCONCIntervention Article Concentration
of intervention article
0
22
21123
MNvit
TXA1ST+
S9C0
S9_C0
22
21ITVCONCUIntervention Article Concentration Unitug/ml
23
22123
MNvit
TXA1ST+
S9C0
S9_C0
23
22

SPDEVID

Sponsor
Applicant-defined device identifierPUFFMASTER3K
24
23123
MNvit
TXA1ST+
S9C0
S9_C0
24
23
DUREFID 

SMKRGM

Smoke
Smoking Regimen
Medium Intensity Regimen
MEDIUM INTENSITY REGIMEN
24
25
123
MNvit
TXA2

(table 1, row 2, ST exposure with S9 at concentration 1250)

ST+S9_C125024MTACTINDMetabolic Activating Agent Name+S9
25123TXA2ST+S9_C125025METACTFLPresence of Metabolic Activation FlagY
26123
ST+S9-12501TESTSYSTest systemTK6 Lymphoblastoid Suspension Cells26123MNvit
TXA2ST+S9
-1250
_C1250
2
26
METACTMetabolic Activation  (this is the type of activation used)

IVTDMIN

In vitro Treatment Duration Minimum3
+S9
27123
MNvit
TXA2ST+S9
-1250
_C1250
3
27
METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)
IVTDTRGIn vitro Treatment Duration Target3.5
Y
28123
MNvit
TXA2ST+S9
-1250
_C1250
4
28
TRTDMIN
IVTDMAXIn vitro Treatment Duration
Minimum
Maximum
3
4
29123
MNvit
TXA2ST+S9
-1250
_C1250
5
29
TRTDTRG
IVTDUIn vitro Treatment Duration
Target
Unit
3.5
HOURS
30123
MNvit
TXA2ST+S9
-1250
_C1250
6
30
TRTDMAX
RCVDMIN
Treatment
Recovery Duration
Maximum
Minimum
4
23.5
31123
MNvit
TXA2ST+S9
-1250
_C1250
7
31
TRTDU
RCVDTRG
Treatment
Recovery Duration
Unit
Target
HOURS
24
32123
MNvit
TXA2ST+S9
-1250
_C1250
8
32
RCVDMIN
RCVDMAXRecovery Duration
Minimum
Maximum
23
24.5
33123
MNvit
TXA2ST+S9
-1250
_C1250
9
33
RCVDTRG
RCVDURecovery Duration
Target
Unit
24
HOURS
34123
MNvit
TXA2ST+S9
-1250
_C1250
10
34
RCVDMAXRecovery Duration Maximum
INCBTMPIncubation Temperature37
24.5
35123
MNvit
TXA2ST+S9
-1250
_C1250
11
35
RCVDU
INCBTMPU
Recovery Duration
Incubation Temperature Unit
HOURS
C
36123
MNvit
TXA2ST+S9
-1250
_C1250
12
36
INCBTMPIncubation Temperature
ATMRHPAtmospheric Relative Humidity Percent50
37
37123
MNvit
TXA2ST+S9
-1250
_C1250
13
37
INCBTMPUIncubation Temperature Unit
ATMCO2PAtmospheric CO2 Percent5
C
38123
MNvit
TXA2ST+S9
-1250
_C1250
14
38
HUMIDAtmospheric Relative Humidity  Percent

SPTOBID

Applicant-defined tobacco identifier

CIG01a
50
39123
MNvit
TXA2ST+S9
-1250
_C1250
15
39
ATMCO2Atmospheric CO2 Percent
EXPTYP

Exposure Type

Submerged
5
40123
MNvit
TXA2ST+S9
-1250
_C1250
16
40
SPTOBID

Sponsor defined tobacco identifier

SAMTYP

Sample Type

Total Particulate Matter in DMSO
CIG01a
41123
MNvit
TXA2ST+S9
-1250
_C1250
17
41
EXPTYP

Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)

ITVNAM

Intervention Article Name

Tobacco ProdA
Submerged
42123
MNvit
TXA2ST+S9
-1250
_C1250
18
42
SAMTYP 
ITVTYPE

Sample Type

(e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical)

Total Particulate Matter in DMSO

Intervention Article Type

Product
43123TXA2ST+S9_C125043ITVCONCIntervention Article Concentration1250
44123
43123MNvit
TXA2ST+S9
-1250
_C1250
19
44
INTRVN
ITVCONCU
Name of the
Intervention Article
Tobacco ProdA
Concentration Unitug/ml
45
44
123
MNvit
TXA2ST+S9
-1250
_C1250
20
45
ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product
SPDEVIDApplicant-defined Device IdentifierPUFFMASTER2023
46123
45123MNvit
TXA2ST+S9
-1250
_C1250
21
46
ITVCONCConcentration of intervention article125046123MNvitTXA2ST+S9-125022ITVCONCUConcentration Unitug/ml47123MNvitTXA2ST+S9-125023SPDEVIDSponsor defined device identifierPUFFMASTER202348123MNvitTXA2ST+S9-125024DUREFIDSmoke RegimenHigh Intensity Regimen... Expand
titleto.xpt (tobacco identifiers, design paramters)

(This is a copy from the SDTM Example. Cigarette Design Parameters)

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.

to.xpt

Row

STUDYID

DOMAIN

SPTOBID

TOSEQ

TOTESTCD

TOTEST

TOCAT

TOORRES

TOORRESU

TOSTRESC

TOSTRESN

TOSTRESU

1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigaretteCigarette2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, CombustedFiltered, Combusted3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USAJoes Cigs USA4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King SizeTreetop Menthol King Size

SMKRGM

Smoking RegimenHIGH INTENSITY REGIMEN
Dataset wrap
Namerelref
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
tableidrelref

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

123

A1

C0
1

EXPERIMENTAL UNIT/TRIAL SET

2

123

A1

C0-Count1C02OBSERVATIONAL UNIT

3

123

A1

C0-Count2C02OBSERVATIONAL UNIT

4

123

A1

C0-Count3C02OBSERVATIONAL UNIT

5

123

A1

C0-Count4C02OBSERVATIONAL UNIT

6

123A2C1250
1EXPERIMENTAL UNIT/TRIAL SET
7123A2C1250-Count1C12502OBSERVATIONAL UNIT
8123A2C1250-Count2C12502OBSERVATIONAL UNIT
9123A2C1250-Count3C12502OBSERVATIONAL UNIT
10123A2C1250-Count4C12502OBSERVATIONAL UNIT

di.xpt (copied v1.0 of medical devices IG)

  • This example is a copy of Example 1 from di.xpt in SDTMIG-MD v1.0 but with values for SPDEVID and DIVAL revised slightly. 
  • Should I remove the FDA UDI (row 5) unless CTP has or plans to establish UDI values?

Example 1
This shows records for two three devices where the sponsor felt that the type, manufacturer, model number, and serial number were necessary for unique identification. In addition, there was a post-marketing UDI identifier available for the first device.

  • Rows 1-5 show the records for a device given a SPDEVID of PUFFMASTER3K
  • Rows 5-8 show the records for a device given a SPDEVID of PUFFMASTER2023
  • Rows 9-12 show
Dataset wrap
Namegt
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
RowSTUDYIDDOMAINGTSEQ

GTREFID

GTTESTCDGTTESTGTCELLEVGTORRESGTORRESU

GTCOLSRT

5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACKHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE2020CIGARETTE
7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm86.086.0mm
8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm26.026.0mm
9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%10.010.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOLMENTHOL
Expand
titledi.xpt (a study reference domain for unique device identification)

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

Expand
titledu.xpt smoke regimen definition (a findings domain for device in-use properties)

 We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine

  • Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
  • Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
  • The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"

du.xpt

Row

STUDYID

DOMAIN

SPDEVID

DUSEQ

DUREFID

DUGRPID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

1123DUPUFFMASTER3K1Medium Intensity RegimenPUFFPROFPuff ProfileSQUARESQUARE2123DUPUFFMASTER3K2Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3123DUPUFFMASTER3K3Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4123DUPUFFMASTER3K4Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

5123DUPUFFMASTER3K5Medium Intensity RegimenNUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

6123DUPUFFMASTER3K6Medium Intensity RegimenPUFFVOLPuff Volume

10

mL

10

10

mL

7123DUPUFFMASTER3K7Medium Intensity RegimenPUFFRNGPuff Range

100-200

100-200

8123DUPUFFMASTER3K8Medium Intensity Regimen1PUFFPAUSPuff Pause

60

s

60

60

s

9123DUPUFFMASTER3K9Medium Intensity Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10123DUPUFFMASTER20231

Canadian Intense Regime

PUFFPROFPuff ProfileSQUARESQUARE11123DUPUFFMASTER20232Canadian Intense Regime

PUFFDUR

Puff Duration

2.00

sec

2.00

2.00

sec

12123DUPUFFMASTER20233Canadian Intense Regime

PUFFINT

Puff Interval

4

PUFF/min

4

4

PUFF/min

13123DUPUFFMASTER20234

Canadian Intense Regime

PUFFBLCK

Puff Block

0

%

0

0

%

14123DUPUFFMASTER20235Canadian Intense RegimeNUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

15123DUPUFFMASTER20236Canadian Intense RegimePUFFVOLPuff Volume

10

mL

10

10

mL

16123DUPUFFMASTER20237

Canadian Intense Regime

PUFFRNGPuff Range

100-200

100-200

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titleei.xpt Entity Identifiers (dm-like)
RowSTUDYIDASSAYIDDOMAINSETCD (from TX)EUIDOBUID1123MNvitEIA11-8-32123MNvitEIA12-8-33123MNvitEIA12-9-34123MNvitEIA23-7-15123MNvitEIA22-7-1 Expand
titlegt.xpt (similar to LB)

A1: Image Removed

A2:                                   Image Removed

  • Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
RowSTUDYIDASSAYIDDOMAINEUID

OBUID

??

GTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)GTORRESGTORRESU

GTCOLSRT

???

GTSTRESCGTSTRESNGTSTRESUGTDTC
1123
MNvit
GT1
-8-3
1
C0

RICC

Relative Increase in Cell Count1540%
00%2022-05-25
2123
MNvit
GT
1-8-3
2C0
2
RCCRelative Cell Count1540%
00%2022-05-25
3123
MNvit
GT
1-8-
3
3
C0RPDRelative Population Doubling1540%
00%2022-05-25
4123
MNvit
GT
GT
4
1
C0-
8-34MNCELLS
Count1MNCEMicronucleated Cells220515
Cells



1515
Cells

2022-05-25
5123
MNvit
GT5
1
C0-
8-35
Count2MNCE
MNCELLS
Micronucleated Cells247413
Cells


1313
Cells

2022-05-25
6123
MNvit
GT
GT
6
1
C0-
8-36
Count3MNCE
MNCELLS
Micronucleated Cells275817
Cells


1717
Cells

2022-05-25
7123
MNvit
GT
GT
7
1
C0-
8-37
Count4MNCE
MNCELLS
Micronucleated Cells266912
Cells


1212
Cells

2022-05-25
8123
MNvit
GT
1-
8
-3
8
C0
AVGRELAverage Relative MN Frequency
MNCECEMicronucleated Cells/Total Cells
0.57%
0.570.57%2022-05-25
9123
MNvit
GT
2-8-3
1C1250
1
RICCRelative Increase in Cell Count13415.7%
15.715.7%2022-05-25
10123
MNvit
GT2
-8-3
2
C1250RCCRelative Cell Count13413.0%
13.013.0%2022-05-25
11123
MNvit
GT
2-8-
3
3
C1250RPDRelative Population Doubling1347.9%
7.97.9%2022-05-25
12123
MNvit
GT
GT
4
2
C1250-
8-34
Count1MNCE
MNCELLS
Micronucleated Cells326620
Cells


2020
Cells

2022-05-25
13123
MNvit
GT
GT
5
2
C1250-
8-35
Count2MNCE
MNCELLS
Micronucleated Cells219017
Cells


1717
Cells

2022-05-25
14123
MNvit
GT
GT
6
2
C1250-
8-36
Count3MNCE
MNCELLS
Micronucleated Cells275813
Cells


1313
Cells

2022-05-25
15123
MNvit
GT
GT
7
2
C1250-
8-37
Count4MNCE
MNCELLS
Micronucleated Cells271421
Cells


2121
Cells

2022-05-25
16123
MNvit
GT
2-
8
-3
8
C1250
AVGREL
MNCECE

Micronucleated Cells/Total Cells

Average Relative MN Frequency


0.66%
0.660.66%2022-05-25
...