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Dataset wrap
Nametx
Rowcaps
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: LAK add F & G to TX and add G data to GT.

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA

A-TA98-C01SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetAA-TA98-C02STRAINStrain/SubstrainTA98
38325064AmesTX

SetA

A-TA98-C03METACTMetabolic ActivationNOT APPLICABLE
48325064AmesTX

SetA

A-TA98-C04METACTFLY/N presence of metabolic activationN
58325064AmesTXSetAA-TA98-C05TRTDMINTreatment Duration Minimum71.5
68325064AmesTXSetAA-TA98-C06TRTDTRGTreatment Duration Target72
78325064AmesTXSetAA-TA98-C07TRTDMAXTreatment Duration Maximum72.5
88325064AmesTXSetAA-TA98-C08TRTDUTreatment Duration UnitHOURS
98325064AmesTXSetAA-TA98-C09INCBTMPIncubation Temperature37
108325064AmesTXSetAA-TA98-C010INCBTMPUIncubation Temperature UnitC
118325064AmesTXSetAA-TA98-C011HUMIDAtmospheric Relative Humidity Percent50
128325064AmesTXSetAA-TA98-C012ATMCO2Atmospheric CO2 Percent5
138325064AmesTXSetAA-TA98-C013SPTOBID

Sponsor defined tobacco identifier

CIG01a
148325064AmesTXSetAA-TA98-C014EXPTYP

Exposure Type

Submerged
158325064AmesTXSetAA-TA98-C015SAMTYP

Sample Type

Total Particulate Matter in PBS
168325064AmesTXSetAA-TA98-C016INTRVN

Name of the intervention article

TA1
178325064AmesTXSetAA-TA98-C017ITVTYPE

Type of intervention article

Vehicle Control
188325064AmesTXSetAA-TA98-C018ITVCONCConcentration of intervention article0
198325064AmesTXSetAA-TA98-C019ITVCONCUConcentration Unitug/plate
208325064AmesTXSetAA-TA98-C020TRTVTreatment VehicleDMSO
218325064AmesTXSetAA-TA98-C021SPDEVIDSponsor defined device identifierPUFFMASTER3K
228325064AmesTXSetAA-TA98-C022DUREFIDSmoke RegimenNON-INTENSE REGIMEN
238325064AmesTX
SetR
SetF
R
F-
TA100
TA98-
C2
C500
1
23SPECIESSpecies
Salmonella typhimurium
SALMONELLA TYPHIMURIUM
248325064AmesTX
SetR
SetF
R
F-
TA100
TA98-
C2
C500
2
24STRAINStrain/Substrain
TA100
TA98
258325064AmesTX
SetR
SetF
R
F-
TA100
TA98-
C2
C500
3
25METACTMetabolic ActivationNOT APPLICABLE
268325064AmesTX
SetR
SetF
R
F-
TA100
TA98-
C2
C500
4
26METACTFLY/N presence of metabolic activationN
278325064AmesTX
SetR
SetF
R
F-
TA100
TA98-
C2
C500
5
27TRTDMINTreatment Duration Minimum71.5
288325064AmesTX

SetR

SetFF-TA98-C50028TRTDTRGTreatment Duration Target72
298325064AmesTXSetFF-TA98-C50029TRTDMAXTreatment Duration Maximum72.5
308325064AmesTXSetFF-TA98-C50030TRTDUTreatment Duration UnitHOURS
318325064AmesTXSetFF-TA98-C50031INCBTMPIncubation Temperature37
328325064AmesTXSetFF-TA98-C50032INCBTMPUIncubation Temperature UnitC
338325064AmesTXSetFF-TA98-C50033HUMIDAtmospheric Relative Humidity Percent50
348325064AmesTXSetFF-TA98-C50034ATMCO2Atmospheric CO2 Percent5
358325064AmesTXSetFF-TA98-C50035SPTOBID

Sponsor defined tobacco identifier

CIG01a
368325064AmesTXSetFF-TA98-C50036EXPTYP

Exposure Type

Submerged
378325064AmesTXSetFF-TA98-C50037SAMTYP

Sample Type

Total Particulate Matter in PBS
388325064AmesTXSetFF-TA98-C50038INTRVN

Name of the intervention article

TA1
398325064AmesTXSetFF-TA98-C50039ITVTYPE

Type of intervention article

Vehicle Control
408325064AmesTXSetFF-TA98-C50040ITVCONCConcentration of intervention article500
418325064AmesTXSetFF-TA98-C50041ITVCONCUConcentration Unitug/plate
428325064AmesTXSetFF-TA98-C50042TRTVTreatment VehicleDMSO
438325064AmesTXSetFF-TA98-C50043SPDEVIDSponsor defined device identifierPUFFMASTER3K
448325064AmesTXSetFF-TA98-C50044DUREFIDSmoke RegimenNON-INTENSE REGIMEN
458325064AmesTXSetGG-TA98-C160045SPECIESSpeciesSALMONELLA TYPHIMURIUM
468325064AmesTXSetGG-TA98-C160046STRAINStrain/SubstrainTA98
478325064AmesTXSetGG-TA98-C160047METACTMetabolic ActivationNOT APPLICABLE
488325064AmesTXSetGG-TA98-C160048METACTFLY/N presence of metabolic activationN
498325064AmesTXSetGG-TA98-C160049TRTDMINTreatment Duration Minimum71.5
508325064AmesTXSetGG-TA98-C160050TRTDTRGTreatment Duration Target72
518325064AmesTXSetGG-TA98-C160051TRTDMAXTreatment Duration Maximum72.5
528325064AmesTXSetGG-TA98-C160052TRTDUTreatment Duration UnitHOURS
538325064AmesTXSetGG-TA98-C160053INCBTMPIncubation Temperature37
548325064AmesTXSetGG-TA98-C160054INCBTMPUIncubation Temperature UnitC
558325064AmesTXSetGG-TA98-C1600
HUMIDAtmospheric Relative Humidity Percent50
568325064AmesTXSetGG-TA98-C1600
ATMCO2Atmospheric CO2 Percent5
578325064AmesTXSetGG-TA98-C1600
SPTOBID

Sponsor defined tobacco identifier

CIG01a
588325064AmesTXSetGG-TA98-C1600
EXPTYP

Exposure Type

Submerged
598325064AmesTXSetGG-TA98-C1600
SAMTYP

Sample Type

Total Particulate Matter in PBS
608325064AmesTXSetGG-TA98-C1600
INTRVN

Name of the intervention article

TA1
618325064AmesTXSetGG-TA98-C1600
ITVTYPE

Type of intervention article

Vehicle Control
628325064AmesTXSetGG-TA98-C1600
ITVCONCConcentration of intervention article1600
638325064AmesTXSetGG-TA98-C1600
ITVCONCUConcentration Unitug/plate
648325064AmesTXSetGG-TA98-C1600
TRTVTreatment VehicleDMSO
658325064AmesTXSetGG-TA98-C1600
SPDEVIDSponsor defined device identifierPUFFMASTER3K
668325064AmesTXSetGG-TA98-C1600
DUREFIDSmoke RegimenNON-INTENSE REGIMEN
678325064AmesTX

SetR

R-TA100-C2
SPECIESSpeciesSalmonella typhimurium
688325064AmesTX

SetR

R-TA100-C2
STRAINStrain/SubstrainTA100
698325064AmesTX

SetR

R-TA100-C2
METACTMetabolic ActivationNOT APPLICABLE
708325064AmesTX

SetR

R-TA100-C2
METACTFLY/N presence of metabolic activationN
718325064AmesTX

SetR

R-TA100-C2
TRTDMINTreatment Duration Minimum71.5
728325064AmesTX

SetR

R-TA100-C2
6

TRTDTRGTreatment Duration Target72
29
738325064AmesTX

SetR

R-TA100-C2
7

TRTDMAXTreatment Duration Maximum72.5
30
748325064AmesTX

SetR

R-TA100-C2
8

TRTDUTreatment Duration UnitHOURS
31
758325064AmesTX

SetR

R-TA100-C2
9

INCBTMPIncubation Temperature37
32
768325064AmesTX

SetR

R-TA100-C2
10

INCBTMPUIncubation Temperature UnitC
33
778325064AmesTX

SetR

R-TA100-C2
11

HUMIDAtmospheric Relative Humidity Percent50
34
788325064AmesTX

SetR

R-TA100-C2
12

ATMCO2Atmospheric CO2 Percent5
35
798325064AmesTX

SetR

R-TA100-C2
13

SPTOBID

Sponsor defined tobacco identifier

CIG01a
36
808325064AmesTX

SetR

R-TA100-C2
14

EXPTYP

Exposure Type

Submerged
37
818325064AmesTX

SetR

R-TA100-C2
15

SAMTYP

Sample Type

Total Particulate Matter in PBS
38
828325064AmesTX

SetR

R-TA100-C2
16

INTRVN

name of the intervention article

TA1
39
838325064AmesTX

SetR

R-TA100-C2
17

ITVTYPE

type of intervention article

Positive Control
40
848325064AmesTX

SetR

R-TA100-C2
18

ITVCONCConcentration of intervention article2
41
858325064AmesTX

SetR

R-TA100-C2
19

ITVCONCUConcentration Unitug/plate
42
868325064AmesTX

SetR

R-TA100-C2
20

TRTVTreatment VehicleDMSO
43
878325064AmesTX

SetR

R-TA100-C2
21

SPDEVIDSponsor defined device identifierPUFFMASTER3K
44
888325064AmesTX

SetR

R-TA100-C2
22

DUREFIDSmoke RegimenNON-INTENSE REGIMEN

REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit.  In the simplified picture of an assay (below), the test tube that contains the possible mutagen is an example of an entity that would have a REFID indicating information at the level of trial set. The petri plate created from that test tube and used to count revertant numbers is an example of an entity that would be at an observational level. 

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