Patient

P2B-131

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 Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine) (Dr. Nolan)

consented 2013-07-09

State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 5

severe assessed 2013-08-15

Grade 3 hypokalaemia with onset in cycle 2 (2013-08-15); assessed as not related to study drug (unlikely); resolved 2013-08-15; action: drug withdrawn.

moderate assessed 2013-08-05

Grade 2 oedema peripheral with onset in cycle 1 (2013-08-05); assessed as not related to study drug (not related); resolved 2013-09-03.

moderate assessed 2013-07-29

Grade 2 thrombocytopenia with onset in cycle 1 (2013-07-29); assessed as related to study drug (probable); resolved 2013-08-05.

mild assessed 2013-07-28

Grade 1 anaemia with onset in cycle 1 (2013-07-28); assessed as related to study drug (probable); resolved 2013-08-11.

mild assessed 2013-07-24

Grade 1 fatigue with onset in cycle 1 (2013-07-24); assessed as not related to study drug (not related); resolved 2013-08-05.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

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