Maximum Tolerated Dose of SDSP-002 Administered Intravenously in Patients with Advanced Solid Tumors Nonrandomized, Control None, Single Group, Open Safety, Treatment COMPLETED 2008-03-01 TABULATIONS LEGACY ANALYSIS LEGACY MedDRA (Adverse Events) 10.0 WHO-DD (Medications) 2007-03 Phase 1 Interventional Studies - Advanced Hematological Malignancies SDSP-002 Administered Intravenously in Patients with Advanced Hematological Malignancies Randomized, Control None, Parallel Assignment, Single Blind, Pharmacokinetic, Treatment COMPLETED 2008-06-01 TABULATIONS LEGACY ANALYSIS LEGACY MedDRA (Adverse Events) 10.0 WHO-DD (Medications) 2007-03 Phase 1 Interventional Studies - Advanced Non-hematological Malignancies
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
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
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
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
Phase 2 Interventional Studies – Patients Previously Enrolled in SDSP-002 Studies Open-Label Rollover Protocol for Patients Previously Enrolled in SDSP-002 Studies Nonrandomized, Control None, Single Group, Open Safety, Treatment PLANNED 2016-10 <forecasted FPV> SDTM v1.2 / SDTM IG 3.1.2 Amendment 1 SDTM define.xml 2.0 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 2.0 Up-version TBD SDTM v1.3/ SDTM IG 3.1.3 CDISC SDTM Terminology TBD MedDRA (Adverse Events/ Medical History) 19.0 WHO-DD (Medications) 2016-03
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-002-03 SDSP-002-04 SDSP-002-05 SDSP-002-06 SDSP-002-07 SDSP-002-08 SDSP-002-09 SDSP-002-10 CURRENT ISS - Relapsed or Refractory Peripheral T-Cell Lymphoma - Interim Analysis 1 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 2.0 CDISC SDTM Terminology 2015-06-26 MedDRA (Adverse Events) 18.1 WHO-DD (Medications) 2015-03 SDSP-002-08 SDSP-002-10 PLANNED ISE - Relapsed or Refractory Peripheral T-Cell Lymphoma - Interim Analysis 1 ADaM v2.1 / ADaM IG 1.0 ADaM define.xml 2.0 SDTM Terminology 2015-06-26 MedDRA (Adverse Events) 18.1 WHO-DD (Medications) 2015-03
SDSP-002-03 SDSP-002-04 SDSP-002-05 SDSP-002-06 SDSP-002-07 SDSP-002-08 SDSP-002-09 SDSP-002-10 SDSP-002-19 Planned ISS – Relapsed or Refractory Ovarian or Breast Cancer - Interim Analysis 1 ADaM v TBD / ADaM IG TBD ADaM define.xml TBD CDISC SDTM Terminology TBD MedDRA (Adverse Events) TBD WHO-DD (Medications) TBD SDSP-002-15 Planned ISE – Relapsed or Refractory Ovarian or Breast Cancer - Interim Analysis 1 ADaM v TBD / ADaM IG TBD ADaM define.xml TBD CDISC SDTM Terminology TBD MedDRA (Adverse Events) TBD WHO-DD (Medications) TBD Non-Conformance to Supported Standards Justification Study Identifier Expected Standard Provided Standard Justification for Non-Conformance to Standards (including Exception Information)
SDSP-002-04 SDSP-002-05 SDSP-002-06 SDTM v1.1 / SDTM IG 3.1.1 ADaM v1.1 define.xml 1.0 SDTM v1.1 (like) ADaM V1.1 (like) define.pdf Item SDTM datasets follow CDISC without supplemental qualifiers. Some ADaM datasets have variables. Studies in CDISC SDTM – Efficacy data is in the EF dataset which has a findings structure Cancer Medications prior to the study are in the PT sponsor defined custom dataset which has an intervention structure There are no trial design datasets for these studies ADaM – Followed as much as possible. Somewhat limited as no IG released. PDF – No define.xml as define.pdf was defined. SDSP-002-10 SDTM v1.2 / SDTM IG 3.1.2 ADaM v2.1 / ADaM IG 1.0 Oncology Domains (draft) ADAE SDTM – Study uses draft Oncology domains (TU, TR, RS) ADaM – Study uses ADAE the new ADaM occurrence model. SDSP-002-15 SDSP-002-20 SDTM v1.3 / SDTM IG 3.2 ADaM v2.1 / ADaM IG 1.0 Oncology Domains (draft) ADAE SDTM – Study uses draft Breast Cancer standards ADaM – Study uses a BDS version of ADAE in addition to ADAE.