Phase 1/2 Interventional Studies Relapsed or Refractory Peripheral T-Cell Lymphoma – Safety, PK and Dose Nonrandomized, COMPLETED 2011-12-01 SDTM v1.2 / CDISC SDTM Escalation of SDSP-002 Control Active, SDTM IG 3.1.2 Terminology Administered Orally with Parallel Assigment, 2011-04-08 CHOP in Patients with Open Label, SDTM Relapsed or Refractory Safety/Pharmacokinetic/ define.xml 1.0 MedDRA Peripheral T-Cell Tolerability, (Adverse Events) Lymphoma Treatment ADaM v2.1 / 14.0 ADaM IG 1.0 WHO-DD ADaM (Medications) define.xml 1.0 2011-03 SDSP-002 Administered Randomized, COMPLETED 2009-02-03 ANALYSIS MedDRA Control Active, LEGACY (Adverse Events) Orally in Patients with Parallel Assignment, 11.1 Relapsed or Refractory Double SDTM v1.1 / Peripheral T-Cell Safety/Efficacy/ SDTM IG 3.1.1 WHO-DD Lymphoma Pharmacokinetic/ (Medications) Pharmacodynamic, SDTM 2008-03 Treatment define.xml 1.0
Phase 1/2 Interventional Studies – Relapsed or Refractory Peripheral T-Cell Lymphoma Safety, PK and Dose Escalation of SDSP-002 Administered Orally with CHOP in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Nonrandomized, Control Active, Parallel Assigment, Open Label, Safety/Pharmacokinetic/ Tolerability, Treatment COMPLETED 2011-12-01 SDTM v1.2 / SDTM IG 3.1.2 SDTM define.xml 1.0 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 1.0 CDISC SDTM Terminology 2011-04-08 MedDRA (Adverse Events) 14.0 WHO-DD (Medications) 2011-03 SDSP-002 Administered Orally in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Randomized, Control Active, Parallel Assignment, Double Safety/Efficacy/ Pharmacokinetic/ Pharmacodynamic, Treatment COMPLETED 2009-02-03 ANALYSIS LEGACY SDTM v1.1 / SDTM IG 3.1.1 SDTM define.xml 1.0 MedDRA (Adverse Events) 11.1 WHO-DD (Medications) 2008-03
SDSP_Example_Oncology.docx