Phase 2 Interventional Studies Patients Previously Enrolled in SDSP-002 Studies – Open-Label Rollover Nonrandomized, PLANNED 2016-10 SDTM v1.2 / CDISC SDTM Control None, <forecasted FPV> SDTM IG 3.1.2 Terminology Protocol for Patients Single Group, Amendment 1 TBD Previously Enrolled in Open SDSP-002 Studies Safety, SDTM MedDRA Treatment define.xml 2.0 (Adverse Events/ Medical History) ADaM v2.1 / 19.0 ADaM IG 1.0 WHO-DD ADaM (Medications) define.xml 2.0 2016-03 Up-version TBD SDTM v1.3/ SDTM IG 3.1.3
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
SDSP_Example_Oncology.docx