Patient
P2B-132
completed Phase IIA Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma · Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania) (Dr. Jansen)
consented 2013-07-10
Adverse events
7
Serious AEs
3
Open data queries
3
Luna dropout signal
—
not on Luna
Adverse events 7
Grade 2 febrile neutropenia with onset in cycle 6 (2013-11-22); assessed as related to study drug (probable); resolved 2013-11-29.
Grade 3 cholecystitis with onset in cycle 4 (2013-09-29); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-10-13.
Grade 2 mucosal inflammation with onset in cycle 3 (2013-09-16); assessed as related to study drug (probable); resolved 2013-09-22.
Grade 1 constipation with onset in cycle 2 (2013-08-20); assessed as not related to study drug (not related); resolved 2013-08-23.
Grade 4 neutropenia with onset in cycle 1 (2013-08-05); assessed as related to study drug (probable); resolved 2013-08-11; action: drug interrupted.
Grade 3 febrile neutropenia with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-10.
Grade 3 mucosal inflammation with onset in cycle 1 (2013-08-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-13.
Data queries 3
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-132 occurred on 2013-09-08, 4 d late against planned day 43 (2013-09-04 ± 3 d, anchored on first dose 2013-07-24). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-132 occurred on 2013-08-18, 4 d late against planned day 22 (2013-08-14 ± 3 d, anchored on first dose 2013-07-24). Confirm the visit date or record a protocol deviation.
AE Neutropenia (grade 4) for P2B-132 (onset 2013-08-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
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