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Expand
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)

                         

33050
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 RegimeISO8325064AmesTXSetARUN

Assay run number

1

8325064AmesTXSetAPORTPort ID8325064AmesTXSetASMPLIDSample ID8325064AmesTXSetASMKFRCSmoke Fraction8325064AmesTXSetAREPNUMReplicate Number18325064AmesTXSetAMEANMean
.8325064AmesTXSetASTDDEVStandard Deviation.8325064AmesTXSetAFOLDINCFold 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 article5500

8325064AmesTXSetF

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetF

STRAINStrain/SubstrainTA98

8325064AmesTXSetF

REGIMESmoking RegimeISO8325064AmesTXSetFARTCONConcentration level of intervention article on plate5008325064AmesTXSetFCONUNITConcentration 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
...








Expand
titlegt.xpt (similar to LB)

Do we need GTMETHOD?

RowSTUDYIDASSAYIDDOMAINTXSETCDPLTWLIDGTSEQGTTESTCDGTTEST
GTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTC
18325064AmesGT
SETA (TA98-DMSO)
SETA 11RPPRevertant Numbers Per Plate26
2626

2015-08-03
28325064AmesGTSETA 22RPPRevertant Numbers Per Plate35
3535

2015-08-03
38325064AmesGTSETA 33RPPRevertant Numbers Per Plate39
3939

2015-08-03
48325064AmesGTSETA 44RPPRevertant Numbers Per Plate35
3535

2015-08-03
58325064AmesGTSETA 55RPPRevertant Numbers Per Plate30
3030
2015-08-03
68325064AmesGTSETA ALL6RPPMEANMean of Revertant Numbers Per Plate33.0
33.033.0

78325064AmesGTSETA ALL7RPPSTDDVStandard Deviation of Revertant Numbers Per Plate5.0
5.05.0

88325064AmesGTSETA ALL8RPPFLDINCFold Increase of Revertant Numbers Per Plate





...














8325064AmesGTSETF151RPPRevertant Numbers Per Plate8
88


8325064AmesGTSETF 162RPPRevertant Numbers Per Plate10
1010


8325064AmesGTSETF 173RPPRevertant Numbers Per Plate
9
12
1212


8325064AmesGTSETFALL6RPPMEANMean of Revertant Numbers Per Plate

10.0



10.0


10.0





8325064Ames
11
GTSETF ALL7RPPSTDDVStandard Deviation of Revertant Numbers Per Plate2.0
2.02.0


8325064AmesGTSETF ALL8RPPFLDINCFold Increase of Revertant Numbers Per Plate0.3
0.30.3

...














8325064AmesGTSETI241RPPRevertant Numbers Per Plate1104
11041104


8325064Ames
12
GTSETI252RPPRevertant Numbers Per Plate1037
10371037


8325064Ames
13
GTSETI263RPPRevertant Numbers Per Plate971
971971


8325064Ames
14
GTSETIALL6RPPMEANMean of Revertant Numbers Per Plate

1037.3



1037.3


1037.3





8325064Ames
15
GTSETIALL7RPPSTDDVStandard Deviation of Revertant Numbers Per Plate66.5
66.566.5


8325064Ames
GTSETIALL8RPPFLDINCFold Increase of Revertant Numbers Per Plate31.4
31.431.4
16


...