1/2 Interventional Studies Relapsed or Refractory Multiple Myeloma – SDSP-002 Administered Nonrandomized, COMPLETED 2008-10-01 TABULATIONS MedDRA Control None, LEGACY (Adverse Events) Intravenously in Patients Single Group, 10.1 with Relapsed or Open Label ANALYSIS Refractory Multiple Safety/Efficacy, LEGACY WHO-DD Myeloma Treatment (Medications) 2008-03 Phase 1/2 Interventional Studies Relapsed/Refractory Amyloidosis – SDSP-002 Administered Randomized, COMPLETED 2010-09-01 SDTM v1.2 / CDISC SDTM Control Active, SDTM IG 3.1.2 Terminology Orally, Weekly in Patients Parallel Assignment, 2010-03-05 with Relapsed/Refractory Single Blind, SDTM Amyloidosis Safety/Efficacy, define.xml 1.0 MedDRA Treatment (Adverse Events) ADaM v1.1 / 12.1 ADaM IG NA WHO-DD ADaM (Medications) define.xml 1.0 2010-03
1/2 Interventional Studies – Relapsed or Refractory Multiple Myeloma SDSP-002 Administered Intravenously in Patients with Relapsed or Refractory Multiple Myeloma Nonrandomized, Control None, Single Group, Open Label Safety/Efficacy, Treatment COMPLETED 2008-10-01 TABULATIONS LEGACY ANALYSIS LEGACY MedDRA (Adverse Events) 10.1 WHO-DD (Medications) 2008-03 Phase 1/2 Interventional Studies – Relapsed/Refractory Amyloidosis SDSP-002 Administered Orally, Weekly in Patients with Relapsed/Refractory Amyloidosis Randomized, Control Active, Parallel Assignment, Single Blind, Safety/Efficacy, Treatment COMPLETED 2010-09-01 SDTM v1.2 / SDTM IG 3.1.2 SDTM define.xml 1.0 ADaM v1.1 / ADaM IG NA ADaM define.xml 1.0 CDISC SDTM Terminology 2010-03-05 MedDRA (Adverse Events) 12.1 WHO-DD (Medications) 2010-03
SDSP_Example_Oncology.docx