Patient

P2B-047

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 · State Health Centre Oncology Department (Budapest, Hungary) (Dr. Clarke)

consented 2012-10-26

State Health Centre Oncology Department (Budapest, Hungary)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

moderate assessed 2013-01-03

Grade 2 fatigue with onset in cycle 3 (2013-01-03); assessed as not related to study drug (not related); not resolved at last follow-up.

mild assessed 2012-12-06

Grade 1 cough with onset in cycle 2 (2012-12-06); assessed as not related to study drug (not related); resolved 2012-12-19.

mild assessed 2012-12-03

Grade 1 hypocalcaemia with onset in cycle 2 (2012-12-03); assessed as not related to study drug (unlikely); resolved 2012-12-14.

moderate assessed 2012-11-06

Grade 2 blood alkaline phosphatase increased with onset in cycle 1 (2012-11-06); assessed as not related to study drug (not related); resolved 2012-11-21.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

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