Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India) › P2B-041

P2B-041

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 2012-10-13

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 stomatitis with onset in cycle 6 (2013-02-16); assessed as related to study drug (probable); resolved 2013-02-25.

mild assessed

Grade 1 fatigue with onset in cycle 6 (2013-02-11); assessed as not related to study drug (not related); resolved 2013-03-10.

mild assessed

Grade 3 tumour haemorrhage with onset in cycle 5 (2013-01-24); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-02-02; action: drug interrupted.

severe serious assessed

Grade 2 pain in extremity with onset in cycle 4 (2013-01-04); assessed as not related to study drug (not related); resolved 2013-01-19.

moderate assessed

Grade 1 cough with onset in cycle 4 (2013-01-03); assessed as not related to study drug (unlikely); resolved 2013-01-10.

mild assessed

Grade 3 nausea with onset in cycle 4 (2012-12-28); assessed as not related to study drug (unlikely); resolved 2012-12-29.

severe assessed

Grade 1 hypocalcaemia with onset in cycle 2 (2012-11-14); assessed as not related to study drug (unlikely); resolved 2012-11-19.

mild assessed

Data queries

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