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This example assumes a design in which the sponsorapplicant-defined protocol specifies the following information. All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:

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Assuming that the protocol also specifies that subjects with blood sampling for TK analysis are experimentally distinct, the factors of interest are the treatment levels and whether the subject is sampled for TK analysis; this leads to 6 trial sets.

The sponsor applicant has chosen to provide the associated arm code, sponsorapplicant-defined group code, group label, set label, dose level and units, control type, whether the trial set is being sampled for TK analysis, and planned number of males and females for each set.

Dataset wrap
Nametx
Dataset2
RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1TDM2TX1Control Group, Vehicle Control once daily, Non-TK1ARMCDArm Code1
2TDM2TX1Control Group, Vehicle Control once daily, Non-TK2SPGRPCDSponsorapplicant-Defined Group Code1
3TDM2TX1Control Group, Vehicle Control once daily, Non-TK3GRPLBLGroup LabelGroup 1, Control
4TDM2TX1Control Group, Vehicle Control once daily, Non-TK4SETLBLSet LabelGroup 1, Control
5TDM2TX1Control Group, Vehicle Control once daily, Non-TK5TRTDOSDose Level0
6TDM2TX1Control Group, Vehicle Control once daily, Non-TK6TRTDOSUDose Unitsmg/kg/day
7TDM2TX1Control Group, Vehicle Control once daily, Non-TK7TCNTRLControl TypeVehicle Control
8TDM2TX1Control Group, Vehicle Control once daily, Non-TK8TKDESCToxicokinetic DescriptionNON-TK
9TDM2TX1Control Group, Vehicle Control once daily, Non-TK9PLANMSUBPlanned Number of Male Subjects7
10TDM2TX1Control Group, Vehicle Control once daily, Non-TK10PLANFSUBPlanned Number of Female Subjects7
11TDM2TX1.TKControl Group, Vehicle Control once daily, TK11ARMCDArm Code1
12TDM2TX1.TKControl Group, Vehicle Control once daily, TK12SPGRPCDSponsorApplicant-Defined Group Code1
13TDM2TX1.TKControl Group, Vehicle Control once daily, TK13GRPLBLGroup LabelGroup 1, Control
14TDM2TX1.TKControl Group, Vehicle Control once daily, TK14SETLBLSet LabelGroup 1, Control - TK
15TDM2TX1.TKControl Group, Vehicle Control once daily, TK15TRTDOSDose Level0
16TDM2TX1.TKControl Group, Vehicle Control once daily, TK16TRTDOSUDose Unitsmg/kg/day
17TDM2TX1.TKControl Group, Vehicle Control once daily, TK17TCNTRLControl TypeVehicle Control
18TDM2TX1.TKControl Group, Vehicle Control once daily, TK18TKDESCToxicokinetic DescriptionTK
19TDM2TX1.TKControl Group, Vehicle Control once daily, TK19PLANMSUBPlanned Number of Male Subjects3
20TDM2TX1.TKControl Group, Vehicle Control once daily, TK20PLANFSUBPlanned Number of Female Subjects3
21TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK21ARMCDArm Code2
22TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK22SPGRPCDSponsorApplicant-Defined Group Code2
23TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK23GRPLBLGroup LabelGroup 2, 100 mg/kg/day
24TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK24SETLBLSet LabelGroup 2, 100 mg/kg/day
25TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK25TRTDOSDose Level100
26TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK26TRTDOSUDose Unitsmg/kg/day
27TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK27TKDESCToxicokinetic DescriptionNON-TK
28TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK28PLANMSUBPlanned Number of Male Subjects7
29TDM2TX2Low-Dose Group, 100 mg/kg Drug a once daily, Non-TK29PLANFSUBPlanned Number of Female Subjects7
30TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK30ARMCDArm Code2
31TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK31SPGRPCDSponsorApplicant-Defined Group Code2
32TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK32GRPLBLGroup LabelGroup 2, 100 mg/kg/day
33TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK33SETLBLSet LabelGroup 2, 100 mg/kg/day - TK
34TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK34TRTDOSDose Level100
35TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK35TRTDOSUDose Unitsmg/kg/day
36TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK36TKDESCToxicokinetic DescriptionTK
37TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK37PLANMSUBPlanned Number of Male Subjects3
38TDM2TX2.TKLow-Dose Group, 100 mg/kg Drug a once daily, TK38PLANFSUBPlanned Number of Female Subjects3
39TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK39ARMCDArm Code3
40TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK40SPGRPCDSponsorApplicant-Defined Group Code3
41TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK41GRPLBLGroup LabelGroup 3, 500 mg/kg/day
42TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK42SETLBLSet LabelGroup 3, 500 mg/kg/day
43TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK43TRTDOSDose Level500
44TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK44TRTDOSUDose Unitsmg/kg/day
45TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK45TKDESCToxicokinetic DescriptionNON-TK
46TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK46PLANMSUBPlanned Number of Male Subjects7
47TDM2TX3High-Dose Group, 500 mg/kg Drug a once daily, Non-TK47PLANFSUBPlanned Number of Female Subjects7
48TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK48ARMCDArm Code3
49TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK49SPGRPCDSponsorApplicant-Defined Group Code3
50TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK50GRPLBLGroup LabelGroup 3, 500 mg/kg/day
51TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK51SETLBLSet LabelGroup 3, 500 mg/kg/day - TK
52TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK52TRTDOSDose Level500
53TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK53TRTDOSUDose Unitsmg/kg/day
54TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK54TKDESCToxicokinetic DescriptionTK
55TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK55PLANMSUBPlanned Number of Male Subjects3
56TDM2TX3.TKHigh-Dose Group, 500 mg/kg Drug a once daily, TK56PLANFSUBPlanned Number of Female Subjects3