Patient

P2B-076

withdrawn Phase II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 · Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania) (Dr. Silva)

consented 2013-02-11

Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 5

severe assessed 2013-04-30

Grade 3 anaemia with onset in cycle 4 (2013-04-30); assessed as related to study drug (probable); resolved 2013-05-15.

mild assessed 2013-04-17

Grade 1 fatigue with onset in cycle 3 (2013-04-17); assessed as not related to study drug (not related); resolved 2013-05-04.

moderate assessed 2013-03-21

Grade 2 stomatitis with onset in cycle 2 (2013-03-21); assessed as related to study drug (probable); resolved 2013-03-29.

moderate assessed 2013-03-16

Grade 2 nausea with onset in cycle 2 (2013-03-16); assessed as not related to study drug (unlikely); resolved 2013-03-20.

mild assessed 2013-03-04

Grade 1 thrombocytopenia with onset in cycle 1 (2013-03-04); assessed as related to study drug (probable); resolved 2013-03-12.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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