The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia) › P2B-075

P2B-075

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
The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia) · Dr. Kowalski
consented 2013-02-04

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 neutropenia with onset in cycle 1 (2013-02-28); assessed as related to study drug (probable); not resolved at last follow-up.

severe assessed

Grade 3 stomatitis with onset in cycle 1 (2013-02-28); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up.

severe serious assessed

Grade 1 thrombocytopenia with onset in cycle 1 (2013-02-28); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2013-02-27); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 5 septic shock with onset in cycle 1 (2013-02-27); serious (death; life-threatening; hospitalization); assessed as related to study drug (probable); fatal outcome on 2013-03-01.

severe serious assessed

Grade 2 stomatitis with onset in cycle 1 (2013-02-27); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-26); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up; action: drug interrupted.

severe serious assessed

Grade 3 dehydration with onset in cycle 1 (2013-02-25); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-28.

severe serious assessed

Data queries

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