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titletx.xpt (trial sets)
  • How do we handle "toxic, no revertant colonies"?  (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
  • Condition of background bacterial lawn?  Slight thinning, Very thin? - refer to SEND team's marked-up table.
    • new Test code of Cytotoxicity with GTORRES = S, V (controlled terms)
    • Each plate we would have one result record for Revertent count and another for the lawn evaluation (NORMAL, SLIGHT THINNING, VERY THIN)
  • When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)


Below the SETS shown in the TX table are rows A, F, I, and R (probably don't need R)         

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA

A-TA98-C0
SPECIESSpeciesSalmonella typhimurium
28325064AmesTXSetAA-TA98-C0
STRAINStrain/SubstrainTA98
38325064AmesTX

SetA (Row 1)

A-TA98-C0
METACTMetabolic Activation  
4





METACTFLY/N presence of metabolic activationN
58325064AmesTXSetA

TRTDMINTreatment Duration Minimum71.5
68325064AmesTXSetA

TRTDTRGTreatment Duration Target72
78325064AmesTXSetA

TRTDMAXTreatment Duration Maximum72.5
88325064AmesTXSetA

TRTDUTreatment Duration UnitHOURS
98325064AmesTXSetA

INCBTMPIncubation Temperature37
108325064AmesTXSetA

INCBTMPUIncubation Temperature UnitC
118325064AmesTXSetA

HUMIDAtmospheric Relative Humidity  Percent50
128325064AmesTXSetA

ATMCO2Atmospheric CO2 Percent5
138325064AmesTXSetA

SPTOBID

Sponsor defined tobacco identifier

CIG01a
148325064AmesTXSetA

EXPTYP

Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)

Submerged
158325064AmesTXSetA

SAMTYP 

Sample Type

Total Particulate Matter in PBS
168325064AmesTXSetA

INTRVN

name of the intervention article

TA1
178325064AmesTXSetA

ITVTYPE

type of intervention article

Vehicle Control
188325064AmesTXSetA

ITVCONCConcentration of intervention article0
198325064AmesTXSetA

ITVCONCUConcentration Unitug/plate
208325064AmesTXSetA

TRTVTreatment VehicleDMSO
218325064AmesTXSetA

SPDEVIDSponsor defined device identifierPUFFMASTER3K
...





DUREFIDSmoke RegimenMedium Intensity Regimen

8325064AmesTX

SetF

(row 6)



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)

TA1

8325064AmesTXSetF

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product

8325064AmesTXSetF

ITVCONCConcentration of intervention article500

8325064AmesTXSetF

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetF

STRAINStrain/SubstrainTA98

8325064AmesTXSetF

REGIMESmoking RegimeISO Regime
...









8325064AmesTX

SetISetG (row 9)7) do G not I!!!



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

8325064AmesTXSetI (row 9)

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

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

...