Jehangir Clinical Development Centre Pvt Ltd (Pune, India) › P2B-064

P2B-064

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
Jehangir Clinical Development Centre Pvt Ltd (Pune, India) · Dr. Tanaka
consented 2012-12-23

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 asthenia with onset in cycle 5 (2013-04-21); assessed as related to study drug (possible); resolved 2013-05-16.

moderate assessed

Grade 1 cough with onset in cycle 5 (2013-04-17); assessed as not related to study drug (unlikely); resolved 2013-05-04.

mild assessed

Grade 2 pyrexia with onset in cycle 5 (2013-04-14); assessed as not related to study drug (not related); resolved 2013-04-16.

moderate assessed

Grade 1 weight decreased with onset in cycle 5 (2013-04-10); assessed as not related to study drug (unlikely); resolved 2013-05-05.

mild assessed

Grade 1 abdominal pain with onset in cycle 5 (2013-04-05); assessed as not related to study drug (unlikely); resolved 2013-04-12.

mild assessed

Grade 3 pyrexia with onset in cycle 4 (2013-03-25); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-03-28.

severe serious assessed

Data queries

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