Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia) › P2B-081

P2B-081

A 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 · Phase II
Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia) · Dr. Dubois
consented 2013-02-28

withdrawn

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 decreased appetite with onset in cycle 2 (2013-04-03); assessed as not related to study drug (unlikely); resolved 2013-04-21.

mild assessed

Grade 4 thrombocytopenia with onset in cycle 1 (2013-03-22); assessed as related to study drug (probable); resolved 2013-03-28.

severe assessed

Grade 2 stomatitis with onset in cycle 1 (2013-03-20); assessed as related to study drug (probable); resolved 2013-03-28.

moderate assessed

Grade 1 hypoalbuminaemia with onset in cycle 1 (2013-03-17); assessed as not related to study drug (unlikely); resolved 2013-04-16.

mild assessed

Grade 1 abdominal pain with onset in cycle 1 (2013-03-16); assessed as not related to study drug (not related); resolved 2013-03-26.

mild assessed

Data queries

AE Thrombocytopenia (grade 4) for P2B-081 (onset 2013-03-22) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Thrombocytopenia 2013-03-22] open