Patient

P2B-012

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 · Blokhin Cancer Research Center (Moscow, Russia) (Dr. Moreau)

consented 2012-06-20

Blokhin Cancer Research Center (Moscow, Russia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 4

moderate assessed 2012-10-10

Grade 2 febrile neutropenia with onset in cycle 5 (2012-10-10); assessed as related to study drug (probable); resolved 2012-10-19.

severe assessed 2012-08-11

Grade 3 anaemia with onset in cycle 2 (2012-08-11); assessed as related to study drug (probable); resolved 2012-08-22; action: drug interrupted.

severe assessed 2012-08-10

Grade 3 neutropenia with onset in cycle 2 (2012-08-10); assessed as related to study drug (probable); resolved 2012-08-15.

severe serious assessed 2012-07-15

Grade 3 febrile neutropenia with onset in cycle 1 (2012-07-15); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-07-23; action: dose reduced.

Data queries 0

No data queries

The CDM sweep raises queries on inconsistent fields.

Luna engagement

This participant doesn't use Luna

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Open Luna users