P2B-026

Noble Hospital Clinical Research Department 1st Floor (Hadapsar, India) › P2B-026

P2B-026

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
Noble Hospital Clinical Research Department 1st Floor (Hadapsar, India) · Dr. Rossi
consented 2012-08-09

completed

AEs

6

Serious

0

Dropout signal

–

Adverse events

6

Grade 2 fatigue with onset in cycle 6 (2012-12-14); assessed as not related to study drug (unlikely); resolved 2013-01-13.

moderate assessed

Grade 2 hypokalaemia with onset in cycle 6 (2012-12-14); assessed as not related to study drug (unlikely); resolved 2012-12-28.

moderate assessed

Grade 2 neutropenia with onset in cycle 5 (2012-11-28); assessed as related to study drug (probable); resolved 2012-12-06.

moderate assessed

Grade 1 aspartate aminotransferase increased with onset in cycle 4 (2012-10-29); assessed as not related to study drug (not related); resolved 2012-11-17.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2012-09-10); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 3 thrombocytopenia with onset in cycle 1 (2012-09-07); assessed as related to study drug (probable); resolved 2012-09-16; action: drug interrupted.

severe assessed

Data queries

0

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