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titletx.xpt (trial sets)
  • 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
  • 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 designations as specified in the trial design.
  • Where is TK6 cell type?  is this test system (see below)
    • needs to be allowed to vary down to the well level / result level
  • Check Essential Data list 

A1:


A2:                                   

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it, more meaningful label for Tables)
TXSEQTXPARMCDTXPARMTXVAL

123MNvitTX

A1

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

ST+S9C01METACTMetabolic Activation  (this is the type of activation used)+S9

123MNvitTXA1ST+S9C02METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y






3TRTDMINTreatment Duration Min (ask Jon the terminology used)






4TRTDTRGTreatment Duration Target






5TRTDMAXTreatment Duration Max






6TRTDUTreatment Duration Unit






7RCVDMINRecovery Duration Min






8RCVDTRGRecovery Duration Target






9RCVDMAXRecovery Duration Max






10RCVDURecovery Duration Unit






11INCBTMPIncubation Temperature






12INCBTMPUIncubation Temperature Unit






13MEDIAComposition of Media






14HUMIDAtmospheric HumidityRelative Humidity  Percent






15ATMCO2Atmospheric CO2 Percent







SPTOBID

Sponsor defined tobacco identifier

CIG01a







SMKEXSYSSmoke Exposure SystemCambridge filter pad, eluted in DMSO

123MNvitTXA1ST+S9C06INTRVN

name of the intervention article

can be:  Tobacco ProdA, Bleomycin (positive control) or Cyclophosphamid A (positive control)

Tobacco ProdA

123MNvitTXA1ST+S9C07ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Negative Control

123MNvitTXA1ST+S9C08ITVCONCConcentration of intervention article0

123MNvitTXA1ST+S9C09ITVCONCUConcentration Unitug/ml

123MNvitTXA1ST+S9C010SPDEVIDSponsor defined device identifierPUFFMASTER3K

123MNvitTXA1ST+S9C011DUREFIDSmoke RegimenMedium Intensity Regimen







SMKEXSYSSmoke Exposure SystemCambridge filter pad, eluted in DMSO

123MNvitTX

A2

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

ST+S9-12501METACTMetabolic Activation  (should there be two parms? Presence, type)?+S9

123MNvitTXA2
2METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y

123MNvitTXA2
3TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)3

123MNvitTXA2
4TRTDRTOLTreatment Duration Tolerance

123MNvitTXA2
5TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)H

123MNvitTXA2
6INTRVNname of the intervention articleTobacco ProdA

123MNvitTXA2
7ITVTYPEtype of intervention articleProduct

123MNvitTXA2
8ITVCONCConcentration of i a 1250

123MNvitTXA2
9ITVCONCUConcentration Unitug/ml

123MNvitTXA2
10SPDEVIDSponsor defined device identifierPUFFMASTER2023

123MNvitTXA2
11DUREFIDSmoke RegimenHigh Intensity Regimen
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