Patient

P2B-097

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 · Royal Hobart Hospital (Hobart, Australia) (Dr. Novak)

consented 2013-04-01

Royal Hobart Hospital (Hobart, Australia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 5

mild assessed 2013-07-03

Grade 1 hypoalbuminaemia with onset in cycle 4 (2013-07-03); assessed as not related to study drug (unlikely); resolved 2013-08-04.

moderate assessed 2013-06-27

Grade 2 oedema peripheral with onset in cycle 4 (2013-06-27); assessed as not related to study drug (unlikely); resolved 2013-08-09.

severe assessed 2013-06-03

Grade 3 fatigue with onset in cycle 3 (2013-06-03); assessed as not related to study drug (unlikely); resolved 2013-06-12; action: drug interrupted.

mild assessed 2013-05-04

Grade 1 pyrexia with onset in cycle 1 (2013-05-04); assessed as not related to study drug (not related); resolved 2013-05-07.

moderate assessed 2013-04-24

Grade 2 nausea with onset in cycle 1 (2013-04-24); assessed as not related to study drug (unlikely); resolved 2013-04-25.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

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