Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) › P2B-085

P2B-085

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
Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) · Dr. Okafor
consented 2013-03-08

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 neutropenia with onset in cycle 6 (2013-07-12); assessed as related to study drug (probable); resolved 2013-07-19; action: drug interrupted.

severe assessed

Grade 2 hypoalbuminaemia with onset in cycle 5 (2013-06-24); assessed as not related to study drug (unlikely); resolved 2013-07-12.

moderate assessed

Grade 2 stomatitis with onset in cycle 5 (2013-06-23); assessed as related to study drug (probable); resolved 2013-06-30.

moderate assessed

Grade 1 asthenia with onset in cycle 3 (2013-05-04); assessed as not related to study drug (not related); resolved 2013-05-21.

mild assessed

Grade 2 alopecia with onset in cycle 2 (2013-04-23); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 1 blood alkaline phosphatase increased with onset in cycle 2 (2013-04-20); assessed as not related to study drug (not related); resolved 2013-05-15.

mild assessed

Data queries

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