State Health Centre Oncology Department (Budapest, Hungary) › P2B-047

P2B-047

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
State Health Centre Oncology Department (Budapest, Hungary) · Dr. Clarke
consented 2012-10-26

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 fatigue with onset in cycle 3 (2013-01-03); assessed as not related to study drug (not related); not resolved at last follow-up.

moderate assessed

Grade 1 cough with onset in cycle 2 (2012-12-06); assessed as not related to study drug (not related); resolved 2012-12-19.

mild assessed

Grade 1 hypocalcaemia with onset in cycle 2 (2012-12-03); assessed as not related to study drug (unlikely); resolved 2012-12-14.

mild assessed

Grade 2 blood alkaline phosphatase increased with onset in cycle 1 (2012-11-06); assessed as not related to study drug (not related); resolved 2012-11-21.

moderate assessed

Data queries

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