Patient

P2B-011

completed Phase II

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 · Sarcoma Oncology Center (Santa Monica, CA) (Dr. Reyes)

consented 2012-06-19

Sarcoma Oncology Center (Santa Monica, CA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 5

moderate assessed 2012-10-23

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

mild assessed 2012-10-18

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

moderate assessed 2012-09-20

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

severe assessed 2012-09-13

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

mild assessed 2012-07-24

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

Data queries 1

serious[Neutropenia 2012-09-13] open

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.

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