Patient

P2B-082

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 2013-03-01

Blokhin Cancer Research Center (Moscow, Russia)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 6

mild assessed 2013-05-21

Grade 1 constipation with onset in cycle 4 (2013-05-21); assessed as not related to study drug (not related); resolved 2013-05-26.

moderate assessed 2013-05-20

Grade 2 blood alkaline phosphatase increased with onset in cycle 4 (2013-05-20); assessed as not related to study drug (not related); resolved 2013-06-03.

mild assessed 2013-05-11

Grade 1 alanine aminotransferase increased with onset in cycle 3 (2013-05-11); assessed as not related to study drug (unlikely); resolved 2013-05-25.

moderate assessed 2013-05-11

Grade 2 thrombocytopenia with onset in cycle 3 (2013-05-11); assessed as related to study drug (probable); resolved 2013-05-22.

moderate assessed 2013-05-08

Grade 2 stomatitis with onset in cycle 3 (2013-05-08); assessed as related to study drug (probable); resolved 2013-05-16.

severe assessed 2013-03-25

Grade 4 neutropenia with onset in cycle 1 (2013-03-25); assessed as related to study drug (probable); resolved 2013-04-01.

Data queries 1

serious[Neutropenia 2013-03-25] open

AE Neutropenia (grade 4) for P2B-082 (onset 2013-03-25) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

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