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NOTE:
Dataset wrap
Nametx.xpt Trial Sets
Rowcaps
Rows 1-22:Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the first row of the raw data table, see the row labeled "SetA" in the table, Raw Data for Study 8325064.
Rows 2-4:Show two records for Alkaline Phosphatase that were collected 1 day apart and are expected to be reported together. Row 4 shows how to create a derived record (average of the Rows 2 and 3) and flag it as Derived (LBDRVFL = "Y") as well as the record to use as baseline (LBBLFL = "Y").
Rows 6-7:Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (e.g., "DIFFERENTIAL").
Row 13:Shows the use of LBUSCHFL to indicate that the test result was obtained from an unscheduled blood collection. In this case, the subject was moribund and a blood sample was taken prior to sacrifice.
Rows 1, 6:Use records in the SUPPLB dataset example to show biological significance assigned by the investigator for test results.
Dataset2
RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA

A-TA98-C01SPECIESSpeciesSalmonella typhimurium
28325064AmesTXSetAA-TA98-C02STRAINStrain/SubstrainTA98
38325064AmesTX

SetA 

A-TA98-C03METACTMetabolic Activation  
48325064AmesTX

SetA 

A-TA98-C04METACTFLY/N presence of metabolic activationN
58325064AmesTXSetAA-TA98-C05TRTDMINTreatment Duration Minimum71.5
68325064AmesTXSetAA-TA98-C06TRTDTRGTreatment Duration Target72
78325064AmesTXSetAA-TA98-C07TRTDMAXTreatment Duration Maximum72.5
88325064AmesTXSetAA-TA98-C08TRTDUTreatment Duration UnitHOURS
98325064AmesTXSetAA-TA98-C09INCBTMPIncubation Temperature37
108325064AmesTXSetAA-TA98-C010INCBTMPUIncubation Temperature UnitC
118325064AmesTXSetAA-TA98-C011HUMIDAtmospheric Relative Humidity  Percent50
128325064AmesTXSetAA-TA98-C012ATMCO2Atmospheric CO2 Percent5
138325064AmesTXSetAA-TA98-C013SPTOBID

Sponsor defined tobacco identifier

CIG01a
148325064AmesTXSetAA-TA98-C014EXPTYP

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

Submerged
158325064AmesTXSetAA-TA98-C015SAMTYP 

Sample Type

Total Particulate Matter in PBS
168325064AmesTXSetAA-TA98-C016INTRVN

name of the intervention article

TA1
178325064AmesTXSetAA-TA98-C017ITVTYPE

type of intervention article

Vehicle Control
188325064AmesTXSetAA-TA98-C018ITVCONCConcentration of intervention article0
198325064AmesTXSetAA-TA98-C019ITVCONCUConcentration Unitug/plate
208325064AmesTXSetAA-TA98-C020TRTVTreatment VehicleDMSO
218325064AmesTXSetAA-TA98-C021SPDEVIDSponsor defined device identifierPUFFMASTER3K
228325064AmesTXSetAA-TA98-C022DUREFIDSmoke RegimenMedium Intensity Regimen
238325064AmesTX

SetF

F-TA98-C5001SPECIESSpecies
248325064AmesTX

SetF

F-TA98-C5002STRAINStrain/Substrain
258325064AmesTX

SetF

F-TA98-C5003METACTMetabolic Activation  
268325064AmesTX

SetF

F-TA98-C5004METACTFLY/N presence of metabolic activationN
278325064AmesTXSetFF-TA98-C500
TRTDRTOLTreatment Duration Tolerance
288325064AmesTXSetFF-TA98-C500
TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

8325064AmesTXSetFF-TA98-C500
INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

TA1

8325064AmesTXSetFF-TA98-C500
ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product

8325064AmesTXSetFF-TA98-C500
ITVCONCConcentration of intervention article500

8325064AmesTXSetFF-TA98-C500
ITVCONCUConcentration Unitug/plate

8325064AmesTXSetFF-TA98-C500
STRAINStrain/SubstrainTA98

8325064AmesTXSetFF-TA98-C500
REGIMESmoking RegimeISO Regime
...











































































































































8325064AmesTX

SetG (row 7) do G not I!!!



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

8325064AmesTXSetG

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

8325064AmesTXSetG

TRTDRTOLTreatment Duration Tolerance

8325064AmesTXSetG

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

8325064AmesTXSetG

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine

8325064AmesTXSetG

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control

8325064AmesTXSetG

ITVCONCConcentration of intervention article5

8325064AmesTXSetG

ITVCONCUConcentration Unitug/plate

8325064AmesTXSetG

REGIMESmoking RegimeISO
...


SetG





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
titletx.xpt (trial sets)
RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA

A-TA98-C01SPECIESSpeciesSalmonella typhimurium
28325064AmesTXSetAA-TA98-C02STRAINStrain/SubstrainTA98
38325064AmesTX

SetA 

A-TA98-C03METACTMetabolic Activation  
48325064AmesTX

SetA 

A-TA98-C04METACTFLY/N presence of metabolic activationN
58325064AmesTXSetAA-TA98-C05TRTDMINTreatment Duration Minimum71.5
68325064AmesTXSetAA-TA98-C06TRTDTRGTreatment Duration Target72
78325064AmesTXSetAA-TA98-C07TRTDMAXTreatment Duration Maximum72.5
88325064AmesTXSetAA-TA98-C08TRTDUTreatment Duration UnitHOURS
98325064AmesTXSetAA-TA98-C09INCBTMPIncubation Temperature37
108325064AmesTXSetAA-TA98-C010INCBTMPUIncubation Temperature UnitC
118325064AmesTXSetAA-TA98-C011HUMIDAtmospheric Relative Humidity  Percent50
128325064AmesTXSetAA-TA98-C012ATMCO2Atmospheric CO2 Percent5
138325064AmesTXSetAA-TA98-C013SPTOBID

Sponsor defined tobacco identifier

CIG01a
148325064AmesTXSetAA-TA98-C014EXPTYP

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

Submerged
158325064AmesTXSetAA-TA98-C015SAMTYP 

Sample Type

Total Particulate Matter in PBS
168325064AmesTXSetAA-TA98-C016INTRVN

name of the intervention article

TA1
178325064AmesTXSetAA-TA98-C017ITVTYPE

type of intervention article

Vehicle Control
188325064AmesTXSetAA-TA98-C018ITVCONCConcentration of intervention article0
198325064AmesTXSetAA-TA98-C019ITVCONCUConcentration Unitug/plate
208325064AmesTXSetAA-TA98-C020TRTVTreatment VehicleDMSO
218325064AmesTXSetAA-TA98-C021SPDEVIDSponsor defined device identifierPUFFMASTER3K
228325064AmesTXSetAA-TA98-C022DUREFIDSmoke RegimenMedium Intensity Regimen
238325064AmesTX

SetF

F-TA98-C5001SPECIESSpecies248325064AmesTX

SetF

F-TA98-C5002STRAINStrain/Substrain258325064AmesTX

SetF

F-TA98-C5003METACTMetabolic Activation  
268325064AmesTX

SetF

F-TA98-C5004METACTFLY/N presence of metabolic activationN
278325064AmesTXSetFF-TA98-C500TRTDRTOLTreatment Duration Tolerance288325064AmesTXSetFF-TA98-C500TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetFF-TA98-C500INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

TA18325064AmesTXSetFF-TA98-C500ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product8325064AmesTXSetFF-TA98-C500ITVCONCConcentration of intervention article5008325064AmesTXSetFF-TA98-C500ITVCONCUConcentration Unitug/plate8325064AmesTXSetFF-TA98-C500STRAINStrain/SubstrainTA988325064AmesTXSetFF-TA98-C500REGIMESmoking RegimeISO Regime...8325064AmesTX

SetG (row 7) do G not I!!!

METACTMetabolic Activation  (should there be two parms? Presence, type)?None8325064AmesTXSetGTRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)8325064AmesTXSetGTRTDRTOLTreatment Duration Tolerance8325064AmesTXSetGTRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetGINTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine8325064AmesTXSetGITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control8325064AmesTXSetGITVCONCConcentration of intervention article58325064AmesTXSetGITVCONCUConcentration Unitug/plate8325064AmesTXSetGREGIMESmoking RegimeISO...SetG8325064AmesTX

SetR

(Row 18)

METACTMetabolic Activation  (should there be two parms? Presence, type)?None8325064AmesTX

SetR

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)8325064AmesTXSetRTRTDRTOLTreatment Duration Tolerance8325064AmesTXSetRTRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetRINTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

4-Nitroquinoline-1-oxide8325064AmesTXSetRITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control8325064AmesTXSetRITVCONCConcentration of intervention article28325064AmesTXSetRITVCONCUConcentration Unitug/plate8325064AmesTXSetRSTRAINStrain/SubstrainTA988325064AmesTXSetRREGIMESmoking RegimeISO
Dataset wrap
Rowcaps

Observational Unit Identifiers (OBUIDs) are defined by the sponsor to uniquely identify the observational unit within an experimental unit. In this example OBUIDs are defined by the sponsor based on the test conditions (trial set) and the unit's location on one of multiple exposure/incubation plates.


Dataset wrap
Rowcaps
Rows 1-5:Show the values for OBUID within the experimental unit identifier for Set A, as defined in the trial set dataset.
Rows 6-8:Show the values for OBUID within the experimental unit identifier for Set F, as defined in the trial set dataset.
Rows 9-11:Show the values for OBUID within the experimental unit identifier for Set G, as defined in the trial set dataset.
Row 12-14:Show the values for OBUID within the experimental unit identifier for Set R, as defined in the trial set dataset.
Dataset2
RowSTUDYIDASSAYIDDOMAINSETCD EUID OBUID  
18325064AmesOUSetAA0_1
28325064AmesOUSetAA0_2
38325064AmesOUSetAA0_3
48325064AmesOUSetAA0_4
58325064AmesOUSetAA0_5

6

8325064AmesOUSetFF6_1
78325064AmesOUSetFF6_2
88325064AmesOUSetFF6_3
98325064AmesOUSetGG7_1
108325064AmesOUSetGG7_2
118325064AmesOUSetG

G

7_3
128325064AmesOUSetRR18_1
138325064AmesOUSetRR18_2
148325064AmesOUSetRR18_3

...