Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) › P2B-089

P2B-089

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 2013-03-18

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 leukopenia with onset in cycle 4 (2013-06-22); assessed as related to study drug (probable); resolved 2013-07-02.

mild assessed

Grade 3 neutropenia with onset in cycle 4 (2013-06-19); assessed as related to study drug (probable); resolved 2013-06-29.

severe assessed

Grade 1 vomiting with onset in cycle 3 (2013-05-24); assessed as not related to study drug (not related); resolved 2013-05-25.

mild assessed

Grade 1 aspartate aminotransferase increased with onset in cycle 2 (2013-05-02); assessed as not related to study drug (unlikely); resolved 2013-05-21.

mild assessed

Grade 2 decreased appetite with onset in cycle 2 (2013-05-01); assessed as not related to study drug (not related); resolved 2013-05-11.

moderate assessed

Grade 2 nausea with onset in cycle 2 (2013-05-01); assessed as not related to study drug (not related); resolved 2013-05-02.

moderate assessed

Data queries

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