Patient

P2B-001

withdrawn Phase II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 2012-01-11

Sarcoma Oncology Center (Santa Monica, CA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

moderate assessed 2012-04-01

Grade 2 cough with onset in cycle 4 (2012-04-01); assessed as not related to study drug (not related); resolved 2012-04-22.

mild assessed 2012-03-30

Grade 1 thrombocytopenia with onset in cycle 4 (2012-03-30); assessed as related to study drug (probable); resolved 2012-04-04.

severe assessed 2012-03-28

Grade 4 anaemia with onset in cycle 4 (2012-03-28); assessed as related to study drug (probable); resolved 2012-04-30.

mild assessed 2012-02-02

Grade 1 alopecia with onset in cycle 1 (2012-02-02); assessed as related to study drug (probable); not resolved at last follow-up.

Data queries 1

serious[Anaemia 2012-03-28] open

AE Anaemia (grade 4) for P2B-001 (onset 2012-03-28) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

Luna engagement

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