Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) › P2B-056

P2B-056

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
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) · Dr. Novak
consented 2012-12-02

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 fatigue with onset in cycle 1 (2012-12-27); assessed as not related to study drug (unlikely); not resolved at last follow-up.

mild assessed

Grade 3 decreased appetite with onset in cycle 1 (2012-12-25); assessed as not related to study drug (not related); not resolved at last follow-up; action: drug interrupted.

severe assessed

Grade 1 constipation with onset in cycle 1 (2012-12-16); assessed as related to study drug (possible); resolved 2012-12-19.

mild assessed

Data queries

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