Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania) › P2B-063

P2B-063

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
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania) · Dr. Jansen
consented 2012-12-21

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 febrile neutropenia with onset in cycle 5 (2013-04-06); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-04-15.

severe serious assessed

Grade 1 diarrhoea with onset in cycle 5 (2013-03-29); assessed as not related to study drug (unlikely); resolved 2013-04-03.

mild assessed

Grade 2 febrile neutropenia with onset in cycle 1 (2013-01-12); assessed as related to study drug (probable); resolved 2013-01-21.

moderate assessed

Grade 2 neutropenia with onset in cycle 1 (2013-01-12); assessed as related to study drug (probable); resolved 2013-01-21.

moderate assessed

Data queries

No data queries. Open queries would appear here for this patient.