SDSP-002 Orally Randomized, COMPLETED 2010-07-09 SDTM v1.1 / CDISC SDTM Control None, SDTM IG 3.1.1 Terminology Administered Drug-drug Cross-Over, 2007-06-05 Interaction with Double Blind, SDTM Ketoconazole in Patients Pharmacokinetic/ define.xml 1.0 MedDRA with Advanced Pharmacodynamic, (Adverse Events) Malignancies Diagnostic ADaM v2.1 / 12.1 ADaM IG 1.0 WHO-DD ADaM (Medications) define.xml 1.0 2009-03 Up-versioned Up-versioned 2015-06-09 2015-06-09 SDTM v1.2/ MedDRA SDTM IG 3.1.2 (Adverse Events) 18.0
SDSP-002 Orally Administered Drug-drug Interaction with Ketoconazole in Patients with Advanced Malignancies Randomized, Control None, Cross-Over, Double Blind, Pharmacokinetic/ Pharmacodynamic, Diagnostic COMPLETED 2010-07-09 SDTM v1.1 / SDTM IG 3.1.1 SDTM define.xml 1.0 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 1.0 Up-versioned 2015-06-09 SDTM v1.2/ SDTM IG 3.1.2 CDISC SDTM Terminology 2007-06-05 MedDRA (Adverse Events) 12.1 WHO-DD (Medications) 2009-03 Up-versioned 2015-06-09 MedDRA (Adverse Events) 18.0
SDSP_Example_Oncology.docx