Patient

P2B-111

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 · Stanford University (Stanford, CA) (Dr. Nolan)

consented 2013-05-10

Stanford University (Stanford, CA)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

moderate assessed 2013-09-22

Grade 2 asthenia with onset in cycle 6 (2013-09-22); assessed as not related to study drug (unlikely); resolved 2013-10-07.

mild assessed 2013-09-10

Grade 1 constipation with onset in cycle 6 (2013-09-10); assessed as not related to study drug (unlikely); resolved 2013-09-13.

mild assessed 2013-07-26

Grade 1 dyspnoea with onset in cycle 4 (2013-07-26); assessed as not related to study drug (not related); resolved 2013-08-23.

moderate assessed 2013-06-09

Grade 2 alopecia with onset in cycle 1 (2013-06-09); assessed as related to study drug (probable); not resolved at last follow-up.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

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