3 Interventional Studies Relapsed or Refractory Peripheral T-Cell Lymphoma – SDSP-002 or Investigator’s Nonrandomized, ONGOING 2012-04-12 SDTM v1.2 / CDISC SDTM SDTM IG 3.1.2 Terminology Control Active, Choice in Patients with 2011-07-22 Cross-Over, Relapsed or Refractory SDTM Double Blind/Open Peripheral T-Cell define.xml 1.0 MedDRA Label, Lymphoma (Adverse Events) Safety/Efficacy/ ADaM v2.1 / 18.1 Pharmacokinetic/ ADaM IG 1.0 Pharmacodynamic, WHO-DD Treatment ADaM (Medications) define.xml 1.0 2015-03 Up-version TBD SDTM v1.3/ SDTM IG 3.1.3 SDTM define.xml 2.0 4.3 Integrated Studies Data Pool Data Pool Pool Exchange Terminology Pool Description Identifier (List of Studies) Status Standards Standards
3 Interventional Studies – Relapsed or Refractory Peripheral T-Cell Lymphoma SDSP-002 or Investigator’s Choice in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Nonrandomized, Control Active, Cross-Over, Double Blind/Open Label, Safety/Efficacy/ Pharmacokinetic/ Pharmacodynamic, Treatment ONGOING 2012-04-12 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 Up-version TBD SDTM v1.3/ SDTM IG 3.1.3 SDTM define.xml 2.0 CDISC SDTM Terminology 2011-07-22 MedDRA (Adverse Events) 18.1 WHO-DD (Medications) 2015-03 4.3 Integrated Studies Data Pool Identifier Data Pool (List of Studies) Pool Status Pool Description Exchange Standards Terminology Standards
SDSP_Example_Oncology.docx