P2B-082

Blokhin Cancer Research Center (Moscow, Russia) › P2B-082

P2B-082

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 · Phase II
Blokhin Cancer Research Center (Moscow, Russia) · Dr. Moreau
consented 2013-03-01

completed

AEs

6

Serious

0

Dropout signal

–

Adverse events

6

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

mild assessed

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.

moderate assessed

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.

mild assessed

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

moderate assessed

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

moderate assessed

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

severe assessed

Data queries

1

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.

serious[Neutropenia 2013-03-25] open