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titletx.xpt (trial sets)
  • Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor applicant designations as specified in the trial design.
  • During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
  • Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
  • Smoke fraction?  is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
  • Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
1123NRUTXCSC-50CSC-501TRTDMINTreatment Duration Minimum47.5
2123NRUTXCSC-50CSC-502TRTDTRGTreatment Duration Target48
3123NRUTXCSC-50CSC-503TRTDMAXTreatment Duration Maximum48.5
4123NRUTXCSC-50CSC-504TRTDUTreatment Duration UnitHOURS
5123NRUTXCSC-50CSC-505INCBTMPIncubation Temperature37
6123NRUTXCSC-50CSC-506INCBTMPUIncubation Temperature UnitC
7123NRUTXCSC-50CSC-507WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
8123NRUTXCSC-50CSC-508HUMIDAtmospheric Relative Humidity  Percent90
9123NRUTXCSC-50CSC-509ATMCO2Atmospheric CO2 Percent5
10123NRUTXCSC-50CSC-5010SPTOBID

Sponsor defined tobacco identifier

CIG01a
11123NRUTXCSC-50CSC-5011EXPTYP

Exposure Type

Air Liquid Interface???
12123NRUTXCSC-50CSC-5012SAMTYPSample TypeWhole Smoke Conditioned Media???
13123NRUTXCSC-50CSC-5013INTRVNName of the Intervention ArticleTobacco ProdA
14123NRUTXCSC-50CSC-5014ITVTYPE
(CT e.g, Product, positive control, negative control, vehicle control, solvent control)
type of intervention articlePRODUCT 
15123NRUTXCSC-50CSC-5015ITVCONCintervention concentration50
16123NRUTXCSC-50CSC-5016ITVCONCUintervention unitug/ml
17123NRUTXCSC-50CSC-5017STRAINStrain/SubstrainSalmonella enterica enterica
18123NRUTXCSC-50CSC-5018SPDEVIDSponsor defined device identifierPUFFMASTER3k
19123NRUTXCSC-50CSC-5019DUREFIDSmoking RegimeMedium Intensity Regimen
20123NRUTXCSC-50CSC-5020SPTOBID

Sponsor defined tobacco identifier

CIG01a
21123NRUTXSLS-110SLS-1101TRTDMINTreatment Duration Minimum47.5
22123NRUTXSLS-110SLS-1102TRTDTRGTreatment Duration Target48
23123NRUTXSLS-110SLS-1103TRTDMAXTreatment Duration Maximum48.5
24123NRUTXSLS-110SLS-1104TRTDUTreatment Duration UnitHOURS
25123NRUTXSLS-110SLS-1105INCBTMPIncubation Temperature37
26123NRUTXSLS-110SLS-1106INCBTMPUIncubation Temperature UnitC
27123NRUTXSLS-110SLS-1107WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
28123NRUTXSLS-110SLS-1108HUMIDAtmospheric Relative Humidity  Percent90
29123NRUTXSLS-110SLS-1109ATMCO2Atmospheric CO2 Percent5
30123NRUTXSLS-110SLS-11010SPTOBID

Sponsor defined tobacco identifier

CIG01a
31123NRUTXSLS-110SLS-11011EXPTYP

Exposure Type

Air Liquid Interface
32123NRUTXSLS-110SLS-11012SAMTYPSample TypeWhole Smoke Conditioned MediaLiquid
33123NRUTXSLS-110SLS-11013INTRVNName of the Intervention ArticleSodium Laurel Sulfate
34123NRUTXSLS-110SLS-11014ITVTYPE
(CT e.g, Product, positive control, negative control, vehicle control, solvent control)
type of intervention articlePOSITIVE CONTROL
35123NRUTXSLS-110SLS-11015ITVCONCintervention concentration200
36123NRUTXSLS-110SLS-11016ITVCONCUintervention unitug/ml
37123NRUTXSLS-110SLS-11017STRAINStrain/SubstrainSalmonella enterica enterica
38123NRUTXSLS-110SLS-11018SPDEVIDSponsor defined device identifierPUFFMASTER3k
39123NRUTXSLS-110SLS-11019DUREFIDSmoking RegimeMedium Intensity Regimen
40123NRUTXSLS-110SLS-11020SPTOBID

Sponsor defined tobacco identifier

CIG01a

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