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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.
  • Do we need "plate counted manually"
  • How do we handle "toxic, no revertant colonies"?
  • Condition of background bacterial lawn?  Slight thinning, Very thin? ?- refer to SEND team's marked-up table.
  • When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)

                         

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA (Row 1)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTXSetA

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)
38325064AmesTXSetA

TRTDRTOLTreatment Duration Tolerance
48325064AmesTXSetA

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
58325064AmesTXSetA

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

DMSO. (or TA1)
68325064AmesTXSetA

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Vehicle Control. (or Product)
78325064AmesTXSetA

ITVCONCConcentration of intervention article0 (null?)
88325064AmesTXSetA

ITVCONCUConcentration Unitug/plate
98325064AmesTXSetA

STRAINStrain/SubstrainTA98
108325064AmesTXSetA

REGIMESmoking RegimeISO

8325064AmesTXSetA

RUN

Assay run number

1


8325064AmesTXSetA

PORTPort ID

8325064AmesTXSetA

SMPLIDSample ID

8325064AmesTXSetA

SMKFRCSmoke Fraction

8325064AmesTXSetA

REPNUMReplicate Number1

8325064AmesTXSetA

MEANMean33.0

8325064AmesTXSetA

STDDEVStandard Deviation5.0

8325064AmesTXSetA

FOLDINCFold Increase
...









8325064AmesTX

SetF

(row 4)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTX

SetF



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

8325064AmesTXSetF

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetF

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

8325064AmesTXSetF

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine

8325064AmesTXSetF

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetF

ITVCONCConcentration of intervention article5

8325064AmesTXSetF

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetF

STRAINStrain/SubstrainTA98

8325064AmesTXSetF

REGIMESmoking RegimeISO

8325064AmesTXSetF

ARTCONConcentration level of intervention article on plate500

8325064AmesTXSetF

CONUNITConcentration level of intervention article on plate, unitug/plate
...









8325064AmesTX

SetI(row 6)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTXSetI

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

8325064AmesTXSetI

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetI

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

8325064AmesTXSetI

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine

8325064AmesTXSetI

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetI

ITVCONCConcentration of intervention article5

8325064AmesTXSetI

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetI

STRAINStrain/SubstrainTA98

8325064AmesTXSetI

REGIMESmoking RegimeISO
...









8325064AmesTX

SetR

(Row 18)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTX

SetR



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

8325064AmesTXSetR

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetR

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

8325064AmesTXSetR

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

4-Nitroquinoline-1-oxide

8325064AmesTXSetR

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetR

ITVCONCConcentration of intervention article2

8325064AmesTXSetR

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetR

STRAINStrain/SubstrainTA98

8325064AmesTXSetR

REGIMESmoking RegimeISO
...


















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