Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) › P2B-034

P2B-034

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
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) · Dr. Novak
consented 2012-09-10

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 anaemia with onset in cycle 6 (2013-01-11); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 1 nausea with onset in cycle 5 (2012-12-14); assessed as not related to study drug (unlikely); resolved 2012-12-19.

mild assessed

Grade 4 neutropenia with onset in cycle 4 (2012-12-03); assessed as related to study drug (probable); resolved 2012-12-10.

severe assessed

Grade 3 cellulitis with onset in cycle 3 (2012-11-13); serious (hospitalization); assessed as not related to study drug (not related); resolved 2012-11-27.

severe serious assessed

Grade 1 leukopenia with onset in cycle 3 (2012-11-12); assessed as related to study drug (probable); resolved 2012-11-22.

mild assessed

Grade 1 fatigue with onset in cycle 3 (2012-11-04); assessed as not related to study drug (not related); resolved 2012-11-22.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2012-10-05); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 aspartate aminotransferase increased with onset in cycle 1 (2012-10-02); assessed as not related to study drug (not related); resolved 2012-10-14.

moderate assessed

Grade 2 dyspnoea with onset in cycle 1 (2012-09-21); assessed as not related to study drug (unlikely); resolved 2012-10-20.

moderate assessed

Data queries

AE Neutropenia (grade 4) for P2B-034 (onset 2012-12-03) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2012-12-03] open