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titletx.xpt (trial sets)

Treatment Duration will be controlled?  During CT definition/reviews will need to decide appropriate Treatment duration values; For now, we just include good example values based on our experience

RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNvitTXA1

METACTMetabolic Activation  (should there be two parms? Presence, type)?+S9
2123MNvitTXA1

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

















TRTDRTOLTreatment Duration Tolerance







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







INTRVNname of the intervention articleBleomycin or Cyclophosphamid A







ITVTYPEtype of intervention articlechoices of values:  product; negative control; positive control
3123MNvitTXA1

PRDCONCITVCONCConcentration of producti a 0
4123MNvitTXA1

PRDCONCUITVCONCUConcentration Unitug/ml
5123MNvitTXA1

ProductProduct Name
6123MNvitTXA1


Smoking Regime
7123MNvitTXA1


Smoke Fraction

123MNvitTXA2

METACTMetabolic Activation+S9

123MNvitTXA2

TRTDURTreatment DurationShort Term

123MNvitTXA2

PRDCONCConcentration of product1250

123MNvitTXA2

PRDCONCUConcentration Unitug/ml

123MNvitTXA2

ProductProduct Name

123MNvitTXA2


Smoking Regime

123MNvitTXA2


Smoke Fraction




A6

METACT








TRTDUR








INTRVNname of the intervention articleCyclophosphamid A







ITVTYPEtype of intervention articlePositive control







ITVCONCConcentration of i a 5




A6

ITVCONCUConcentration Unitug/ml




A6

TCNTL


123MNvitTX

B1



METACTMetabolic Activation-S9

123MNvitTX

B1



TRTDRTRGTreatment Duration target4







TRTDRTOLTreatment Duration Tolerance.25
??123MNvitTXB1

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

123MNvitTX

B1



PRDCONCConcentration of product0

123MNvitTX

B1



PRDCONCUConcentration Unitug/ml

123MNvitTXB1

ProductProduct Name

123MNvitTXB1


Smoking Regime

123MNvitTXB1


Smoke Fraction

123MNvitTX

C1



METACTMetabolic Activation-S9

123MNvitTX

C1



TRTDURTreatment Duration24
??123MNvitTXC1

TRTDURUTreatment Duration UnitH

123MNvitTX

C1



PRDCONCConcentration of product0

123MNvitTX

C1



PRDCONCUConcentration Unitug/ml

123MNvitTX

C1



ProductProduct Name

123MNvitTXC1


Smoking Regime

123MNvitTX

C1




Smoke Fraction
Expand
titlegt.xpt (similar to LB)
RowSTUDYIDASSAYIDDOMAINTXCDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTCGTNOMDYGTELTMGTTPTREF




A61RICC















2...















8AVGREL










1123MNvitGTA21RICC
13415.7%15.715.7%2022-05-25


2123MNvitGTA22RCC
13413.0%13.013.0%2022-05-25


3123MNvitGTA23RPD
1347.9%7.97.9%2022-05-25


4123MNvitGTA24MNCELLSMicronucleated Cells326620Cells2020Cells2022-05-25


5123MNvitGTA25MNCELLSMicronucleated Cells219017Cells1717Cells2022-05-25


6123MNvitGTA26MNCELLSMicronucleated Cells275813Cells1313Cells2022-05-25


7123MNvitGTA27MNCELLSMicronucleated Cells271421Cells2121Cells2022-05-25


8123MNvitGTA28AVGRELAverage Relative MN Frequency
0.66%0.660.66%2022-05-25


9123MNvitGTA11RICC
1540%00%2022-05-25


10123MNvitGTA12RCC
1540%00%2022-05-25


11123MNvitGTA13RPD
1540%00%2022-05-25


12123MNvitGTA14MNCELLSMicronucleated Cells326615Cells1515Cells2022-05-25


13123MNvitGTA15MNCELLSMicronucleated Cells219013Cells1313Cells2022-05-25


14123MNvitGTA16MNCELLSMicronucleated Cells275817Cells1717Cells2022-05-25


15123MNvitGTA17MNCELLSMicronucleated Cells271412Cells1212Cells2022-05-25


16123MNvitGTA18AVGRELAverage Relative MN Frequency
0.57%0.570.57%2022-05-25










































































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