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Nametx
Rowcaps
Rows 1-14:Show trial set, SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species Salmonella Typhimurium. 
Rows 15, 24, 33, 42:Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM.  As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM.
Rows 16-23: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 25-32:Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064.
Rows 33-41:Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 42-50:Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Row 10:

Shows 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).

Row 13:

Shows 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).

Row 14:

Shows 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

 

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

2TRTDMINIn vitro Treatment Duration Minimum71.5
38325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM3TRTDTRGIn vitro Treatment Duration Target72
48325064AmesTXSetSTMSALMONELLA TYPHIMURIUM4TRTDMAXIn vitro Treatment Duration Maximum72.5
58325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

5TRTDUIn vitro Treatment Duration UnitHOURS
68325064AmesTXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

8HUMIDAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2Atmospheric CO2 Percent5
108325064AmesTXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Sponsor defined tobacco identifier

CIG01a
118325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064AmesTXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDSponsor defined device identifierPUFFMASTER3K
148325064AmesTXSetSTMSALMONELLA TYPHIMURIUM14DUREFIDSmoke RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
168325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064AmesTX

SetA

A-TA98-C016METACTMetabolic ActivationNOT APPLICABLE
188325064AmesTX

SetA

A-TA98-C017METACTFLY/N presence of metabolic activationN
198325064AmesTXSetAA-TA98-C018INTRVN

Name of the intervention article

TA1
208325064AmesTXSetAA-TA98-C019ITVTYPE

Type of intervention article

Vehicle Control
218325064AmesTXSetAA-TA98-C020ITVCONCConcentration of intervention article0
228325064AmesTXSetAA-TA98-C021ITVCONCUConcentration Unitug/plate
238325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
248325064AmesTXSetFF-TA98-C500
PSETCDParent Set CodeSetSTM
258325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
268325064AmesTXSetFF-TA98-C50024METACTMetabolic ActivationNOT APPLICABLE
278325064AmesTXSetFF-TA98-C50025METACTFLY/N presence of metabolic activationN
288325064AmesTXSetFF-TA98-C50026INTRVN

Name of the intervention article

TA1
298325064AmesTXSetFF-TA98-C50027ITVTYPE

Type of intervention article

Product
308325064AmesTXSetFF-TA98-C50028ITVCONCConcentration of intervention article500
318325064AmesTXSetFF-TA98-C50029ITVCONCUConcentration Unitug/plate
328325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSO
338325064AmesTXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
348325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
358325064AmesTXSetGG-TA98-C160032METACTMetabolic ActivationNOT APPLICABLE
368325064AmesTXSetGG-TA98-C160033METACTFLY/N presence of metabolic activationN
378325064AmesTXSetGG-TA98-C160034INTRVN

Name of the intervention article

TA1
388325064AmesTXSetGG-TA98-C160035ITVTYPE

Type of intervention article

Product
398325064AmesTXSetGG-TA98-C160036ITVCONCConcentration of intervention article1600
408325064AmesTXSetGG-TA98-C160037ITVCONCUConcentration Unitug/plate
418325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
428325064AmesTX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
438325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
448325064AmesTX

SetR

R-TA100-C240METACTMetabolic ActivationNOT APPLICABLE
458325064AmesTX

SetR

R-TA100-C241METACTFLY/N presence of metabolic activationN
468325064AmesTX

SetR

R-TA100-C242INTRVN

name of the intervention article

NaN3
478325064AmesTX

SetR

R-TA100-C243ITVTYPE

type of intervention article

Positive Control
488325064AmesTX

SetR

R-TA100-C244ITVCONCConcentration of intervention article2
498325064AmesTX

SetR

R-TA100-C245ITVCONCUConcentration Unitug/plate
508325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

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