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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 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 Check row captions and other red font items (SET for Set STM).  and added G data to GT.  Add SetSTM anywhere else? (RELREF?)

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetSTM

A-TA98-C0STM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetSTMA-TA98-C02TRTDMINTreatment Duration Minimum71.5
38325064AmesTX

SetSTM

A-TA98-C03TRTDTRGTreatment Duration Target72
48325064AmesTXSetSTMA-TA98-C04TRTDMAXTreatment Duration Maximum72.5
58325064AmesTX

SetSTM

A-TA98-C05TRTDUTreatment Duration UnitHOURS
68325064AmesTXSetSTMA-TA98-C06INCBTMPIncubation Temperature37
78325064AmesTX

SetSTM

A-TA98-C07INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTMA-TA98-C08HUMIDAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

A-TA98-C09ATMCO2Atmospheric CO2 Percent5
108325064AmesTXSetSTMA-TA98-C010SPTOBID

Sponsor defined tobacco identifier

CIG01a
118325064AmesTX

SetSTM

A-TA98-C011EXPTYP

Exposure Type

Submerged
128325064AmesTXSetSTMA-TA98-C012SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064AmesTXSetSTMA-TA98-C013SPDEVIDSponsor defined device identifierPUFFMASTER3K
148325064AmesTXSetSTMA-TA98-C014DUREFIDSmoke RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
168325064AmesTX

SetA

A-TA98-C016METACTMetabolic ActivationNOT APPLICABLE
178325064AmesTX

SetA

A-TA98-C017METACTFLY/N presence of metabolic activationN
188325064AmesTXSetAA-TA98-C018INTRVN

Name of the intervention article

TA1
198325064AmesTXSetAA-TA98-C019ITVTYPE

Type of intervention article

Vehicle Control
208325064AmesTXSetAA-TA98-C020ITVCONCConcentration of intervention article0
218325064AmesTXSetAA-TA98-C021ITVCONCUConcentration Unitug/plate
228325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
238325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
248325064AmesTXSetFF-TA98-C50024METACTMetabolic ActivationNOT APPLICABLE
258325064AmesTXSetFF-TA98-C50025METACTFLY/N presence of metabolic activationN
268325064AmesTXSetFF-TA98-C50026INTRVN

Name of the intervention article

TA1
278325064AmesTXSetFF-TA98-C50027ITVTYPE

Type of intervention article

Product
288325064AmesTXSetFF-TA98-C50028ITVCONCConcentration of intervention article500
298325064AmesTXSetFF-TA98-C50029ITVCONCUConcentration Unitug/plate
308325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSO
318325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
328325064AmesTXSetGG-TA98-C160032METACTMetabolic ActivationNOT APPLICABLE
338325064AmesTXSetGG-TA98-C160033METACTFLY/N presence of metabolic activationN
348325064AmesTXSetGG-TA98-C160034INTRVN

Name of the intervention article

TA1
358325064AmesTXSetGG-TA98-C160035ITVTYPE

Type of intervention article

Product
368325064AmesTXSetGG-TA98-C160036ITVCONCConcentration of intervention article1600
378325064AmesTXSetGG-TA98-C160037ITVCONCUConcentration Unitug/plate
388325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
398325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
408325064AmesTX

SetR

R-TA100-C240METACTMetabolic ActivationNOT APPLICABLE
418325064AmesTX

SetR

R-TA100-C241METACTFLY/N presence of metabolic activationN
428325064AmesTX

SetR

R-TA100-C242INTRVN

name of the intervention article

NaN3
438325064AmesTX

SetR

R-TA100-C243ITVTYPE

type of intervention article

Positive Control
448325064AmesTX

SetR

R-TA100-C244ITVCONCConcentration of intervention article2
458325064AmesTX

SetR

R-TA100-C245ITVCONCUConcentration Unitug/plate
468325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

...