P2B-112

The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia) › P2B-112

P2B-112

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 2013-05-12

completed

AEs

9

Serious

0

Dropout signal

–

Adverse events

9

Grade 3 anaemia with onset in cycle 6 (2013-09-26); assessed as related to study drug (probable); resolved 2013-10-10; action: drug interrupted.

severe assessed

Grade 2 cough with onset in cycle 5 (2013-08-23); assessed as not related to study drug (unlikely); resolved 2013-09-17.

moderate assessed

Grade 1 constipation with onset in cycle 5 (2013-08-22); assessed as not related to study drug (unlikely); resolved 2013-08-28.

mild assessed

Grade 1 dyspnoea with onset in cycle 3 (2013-07-25); assessed as not related to study drug (unlikely); resolved 2013-08-13.

mild assessed

Grade 2 asthenia with onset in cycle 3 (2013-07-24); assessed as not related to study drug (not related); resolved 2013-08-05.

moderate assessed

Grade 1 mucosal inflammation with onset in cycle 3 (2013-07-19); assessed as related to study drug (probable); resolved 2013-07-28.

mild assessed

Grade 1 weight decreased with onset in cycle 2 (2013-07-05); assessed as not related to study drug (unlikely); resolved 2013-08-22.

mild assessed

Grade 1 pyrexia with onset in cycle 2 (2013-06-24); assessed as not related to study drug (unlikely); resolved 2013-06-28.

mild assessed

Grade 1 stomatitis with onset in cycle 1 (2013-06-07); assessed as related to study drug (probable); resolved 2013-06-13.

mild assessed

Data queries

0

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