Phase 2 Interventional Studies Acute Myelogenous Leukemia – SDSP-002 Administered Nonrandomized, COMPLETED 2009-02-10 SDTM v1.1 / MedDRA Control Active, SDTM IG 3.1.1 (Adverse Events) Orally in Patients with Parallel, 11.1 Acute Myelogenous Double Blind, SDTM Leukemia Safety/Efficacy/ define.xml 1.0 WHO-DD Pharmacokinetic/ (Medications) Pharmacodynamic, ANALYSIS 2008-03 Treatment LEGACY Phase 2 Interventional Studies Relapsed or Refractory Ovarian or Breast Cancer – SDSP-002 in Patients with Nonrandomized, COMPLETED 2009-03-25 SDTM v1.2 / MedDRA Relapsed or Refractory Control Active, SDTM IG 3.1.2 (Adverse Events) Ovarian or Breast Cancer Parallel Assignment, Amendment 1 11.1 Open Label, Safety/Efficacy/ SDTM WHO-DD Pharmacokinetic/ define.xml 1.0 (Medications) Pharmacodynamic, 2008-03 Treatment ADaM v1.1 / ADaM IG NA ADaM define.xml 1.0
Phase 2 Interventional Studies – Acute Myelogenous Leukemia SDSP-002 Administered Orally in Patients with Acute Myelogenous Leukemia Nonrandomized, Control Active, Parallel, Double Blind, Safety/Efficacy/ Pharmacokinetic/ Pharmacodynamic, Treatment COMPLETED 2009-02-10 SDTM v1.1 / SDTM IG 3.1.1 SDTM define.xml 1.0 ANALYSIS LEGACY MedDRA (Adverse Events) 11.1 WHO-DD (Medications) 2008-03 Phase 2 Interventional Studies – Relapsed or Refractory Ovarian or Breast Cancer SDSP-002 in Patients with Relapsed or Refractory Ovarian or Breast Cancer Nonrandomized, Control Active, Parallel Assignment, Open Label, Safety/Efficacy/ Pharmacokinetic/ Pharmacodynamic, Treatment COMPLETED 2009-03-25 SDTM v1.2 / SDTM IG 3.1.2 Amendment 1 SDTM define.xml 1.0 ADaM v1.1 / ADaM IG NA ADaM define.xml 1.0 MedDRA (Adverse Events) 11.1 WHO-DD (Medications) 2008-03
SDSP_Example_Oncology.docx