Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India) › P2B-051

P2B-051

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
Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India) · Dr. Ito
consented 2012-11-06

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 hypoalbuminaemia with onset in cycle 4 (2013-02-06); assessed as not related to study drug (not related); resolved 2013-03-10.

mild assessed

Grade 3 hypokalaemia with onset in cycle 4 (2013-02-02); assessed as not related to study drug (unlikely); resolved 2013-02-07; action: drug interrupted.

severe assessed

Grade 1 decreased appetite with onset in cycle 2 (2012-12-19); assessed as not related to study drug (not related); resolved 2012-12-31.

mild assessed

Grade 1 nausea with onset in cycle 2 (2012-12-13); assessed as not related to study drug (unlikely); resolved 2012-12-15.

mild assessed

Data queries

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