P2B-066

Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India) › P2B-066

P2B-066

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 2013-01-05

completed

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 2 nausea with onset in cycle 4 (2013-03-20); assessed as not related to study drug (not related); resolved 2013-03-25.

moderate assessed

Grade 1 fatigue with onset in cycle 4 (2013-03-18); assessed as not related to study drug (unlikely); resolved 2013-03-29.

mild assessed

Grade 3 neutropenia with onset in cycle 2 (2013-02-13); assessed as related to study drug (probable); resolved 2013-02-19.

severe assessed

Grade 1 oedema peripheral with onset in cycle 2 (2013-02-12); assessed as not related to study drug (not related); resolved 2013-03-13.

mild assessed

Grade 2 pyrexia with onset in cycle 2 (2013-02-12); assessed as not related to study drug (not related); resolved 2013-02-14.

moderate assessed

Data queries

0

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