Royal North Shore (St Leonards, Australia) › P2B-115

P2B-115

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
Royal North Shore (St Leonards, Australia) · Dr. Rossi
consented 2013-05-20

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 decreased appetite with onset in cycle 6 (2013-09-29); assessed as not related to study drug (not related); resolved 2013-10-10; action: drug interrupted.

severe assessed

Grade 1 abdominal pain with onset in cycle 5 (2013-09-13); assessed as not related to study drug (not related); resolved 2013-09-21.

mild assessed

Grade 3 anaemia with onset in cycle 5 (2013-09-08); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-29; action: dose reduced.

severe serious assessed

Grade 1 anaemia with onset in cycle 4 (2013-08-25); assessed as related to study drug (probable); resolved 2013-09-21.

mild assessed

Grade 1 nausea with onset in cycle 3 (2013-07-20); assessed as not related to study drug (not related); resolved 2013-07-23.

mild assessed

Grade 2 neutropenia with onset in cycle 2 (2013-07-08); assessed as related to study drug (probable); resolved 2013-07-16.

moderate assessed

Grade 2 alopecia with onset in cycle 1 (2013-06-21); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Data queries

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