Patient

P2B-037

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 · Pennsylvania Hematology Oncology Associates (Philadelphia, PA) (Dr. Tanaka)

consented 2012-09-23

Pennsylvania Hematology Oncology Associates (Philadelphia, PA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

moderate assessed 2012-11-07

Grade 2 nausea with onset in cycle 2 (2012-11-07); assessed as not related to study drug (not related); resolved 2012-11-11.

mild assessed 2012-11-06

Grade 1 vomiting with onset in cycle 2 (2012-11-06); assessed as not related to study drug (not related); resolved 2012-11-09.

mild assessed 2012-10-23

Grade 1 anaemia with onset in cycle 1 (2012-10-23); assessed as related to study drug (probable); not resolved at last follow-up.

severe serious assessed 2012-10-13

Grade 3 urinary tract infection with onset in cycle 1 (2012-10-13); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-10-22.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

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