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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

A1:


A2:                                   

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL

123MNvitTX

A1

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



METACTMetabolic Activation  (should there be two parms? Presence, type)?this is the type of activation used)+S9

123MNvitTXA1

METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)

123MNvitTXA1

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

123MNvitTXA1

TRTDRTOLTreatment Duration Tolerance

123MNvitTXA1

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

123MNvitTXA1

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

Tobacco ProdA

123MNvitTXA1

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product

123MNvitTXA1

ITVCONCConcentration of intervention article0

123MNvitTXA1

ITVCONCUConcentration Unitug/ml

123MNvitTSA1
SPDEVIDSponsor defined device identifierPUFFMASTER3K

123MNvitTSA1
DUREFIDSmoke RegimenMedium Intensity Regimen

123MNvitTX

A2

(table 1, row 2)



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

123MNvitTXA2

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

123MNvitTXA2

TRTDRTOLTreatment Duration Tolerance

123MNvitTXA2

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

123MNvitTXA2

INTRVNname of the intervention articleTobacco ProdA

123MNvitTXA2

ITVTYPEtype of intervention articleProduct

123MNvitTXA2

ITVCONCConcentration of i a 1250

123MNvitTXA2

ITVCONCUConcentration Unitug/ml

123MNvitTSA2
SPDEVIDSponsor defined device identifierPUFFMASTER2023

123MNvitTSA2
DUREFIDSmoke RegimenHigh Intensity Regimen
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