Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine) › P2B-035

P2B-035

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
Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine) · Dr. Tanaka
consented 2012-09-11

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 mucosal inflammation with onset in cycle 6 (2013-01-18); assessed as related to study drug (probable); resolved 2013-01-25.

mild assessed

Grade 1 nausea with onset in cycle 6 (2013-01-07); assessed as not related to study drug (unlikely); resolved 2013-01-10.

mild assessed

Grade 2 mucosal inflammation with onset in cycle 5 (2012-12-27); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-01-05.

moderate serious assessed

Grade 2 febrile neutropenia with onset in cycle 4 (2012-12-08); assessed as related to study drug (probable); resolved 2012-12-17.

moderate assessed

Grade 1 hypoalbuminaemia with onset in cycle 3 (2012-11-13); assessed as not related to study drug (unlikely); resolved 2012-12-17.

mild assessed

Grade 3 febrile neutropenia with onset in cycle 1 (2012-10-07); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-10-13.

severe serious assessed

Data queries

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