Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania) › P2B-083

P2B-083

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
Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania) · Dr. Silva
consented 2013-03-02

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 anaemia with onset in cycle 5 (2013-06-21); assessed as related to study drug (probable); resolved 2013-07-28; action: drug interrupted.

severe assessed

Grade 2 nausea with onset in cycle 5 (2013-06-10); assessed as not related to study drug (unlikely); resolved 2013-06-15.

moderate assessed

Grade 2 pain in extremity with onset in cycle 4 (2013-06-05); assessed as not related to study drug (not related); resolved 2013-07-04.

moderate assessed

Grade 2 hypocalcaemia with onset in cycle 3 (2013-05-16); assessed as not related to study drug (not related); resolved 2013-05-22.

moderate assessed

Grade 1 stomatitis with onset in cycle 2 (2013-04-15); assessed as related to study drug (probable); resolved 2013-04-20.

mild assessed

Grade 3 neutropenia with onset in cycle 2 (2013-04-12); assessed as related to study drug (probable); resolved 2013-04-18.

severe assessed

Grade 3 cellulitis with onset in cycle 2 (2013-04-09); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-04-20; action: drug interrupted.

severe serious assessed

Grade 1 blood alkaline phosphatase increased with onset in cycle 1 (2013-04-04); assessed as not related to study drug (not related); resolved 2013-04-22.

mild assessed

Data queries

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