Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia) › P2B-090

P2B-090

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 2013-03-21

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 anaemia with onset in cycle 5 (2013-07-19); assessed as related to study drug (probable); resolved 2013-08-14.

mild assessed

Grade 1 nausea with onset in cycle 5 (2013-07-04); assessed as not related to study drug (unlikely); resolved 2013-07-07.

mild assessed

Grade 1 fatigue with onset in cycle 4 (2013-06-27); assessed as not related to study drug (unlikely); resolved 2013-07-08.

mild assessed

Grade 3 febrile neutropenia with onset in cycle 4 (2013-06-14); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-22.

severe serious assessed

Grade 1 thrombocytopenia with onset in cycle 2 (2013-05-06); assessed as related to study drug (probable); resolved 2013-05-18.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2013-04-19); assessed as related to study drug (probable); resolved 2013-04-24.

moderate assessed

Grade 1 neutropenia with onset in cycle 1 (2013-04-14); assessed as related to study drug (probable); resolved 2013-04-23.

mild assessed

Data queries

No data queries. Open queries would appear here for this patient.