P2B-076

Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania) › P2B-076

P2B-076

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 2013-02-11

withdrawn

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 3 anaemia with onset in cycle 4 (2013-04-30); assessed as related to study drug (probable); resolved 2013-05-15.

severe assessed

Grade 1 fatigue with onset in cycle 3 (2013-04-17); assessed as not related to study drug (not related); resolved 2013-05-04.

mild assessed

Grade 2 stomatitis with onset in cycle 2 (2013-03-21); assessed as related to study drug (probable); resolved 2013-03-29.

moderate assessed

Grade 2 nausea with onset in cycle 2 (2013-03-16); assessed as not related to study drug (unlikely); resolved 2013-03-20.

moderate assessed

Grade 1 thrombocytopenia with onset in cycle 1 (2013-03-04); assessed as related to study drug (probable); resolved 2013-03-12.

mild assessed

Data queries

0

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