P2B-011

Sarcoma Oncology Center (Santa Monica, CA) › P2B-011

P2B-011

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
Sarcoma Oncology Center (Santa Monica, CA) · Dr. Reyes
consented 2012-06-19

completed

AEs

5

Serious

0

Dropout signal

–

Adverse events

5

Grade 2 pyrexia with onset in cycle 6 (2012-10-23); assessed as not related to study drug (unlikely); resolved 2012-10-25.

moderate assessed

Grade 1 abdominal pain with onset in cycle 6 (2012-10-18); assessed as not related to study drug (unlikely); resolved 2012-10-24.

mild assessed

Grade 2 anaemia with onset in cycle 4 (2012-09-20); assessed as related to study drug (probable); resolved 2012-10-23.

moderate assessed

Grade 4 neutropenia with onset in cycle 4 (2012-09-13); assessed as related to study drug (probable); resolved 2012-09-19.

severe assessed

Grade 1 hypokalaemia with onset in cycle 1 (2012-07-24); assessed as not related to study drug (not related); resolved 2012-07-31.

mild assessed

Data queries

1

AE Neutropenia (grade 4) for P2B-011 (onset 2012-09-13) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2012-09-13] open