State Health Centre Oncology Department (Budapest, Hungary) › P2B-070

P2B-070

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
State Health Centre Oncology Department (Budapest, Hungary) · Dr. Clarke
consented 2013-01-18

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 dyspnoea with onset in cycle 5 (2013-05-08); assessed as not related to study drug (not related); resolved 2013-05-22.

moderate assessed

Grade 1 asthenia with onset in cycle 4 (2013-04-28); assessed as not related to study drug (not related); resolved 2013-05-12.

mild assessed

Grade 2 hypoalbuminaemia with onset in cycle 4 (2013-04-23); assessed as not related to study drug (unlikely); resolved 2013-06-03.

moderate assessed

Grade 2 febrile neutropenia with onset in cycle 4 (2013-04-20); assessed as related to study drug (probable); resolved 2013-04-28.

moderate assessed

Grade 1 stomatitis with onset in cycle 3 (2013-03-24); assessed as related to study drug (probable); resolved 2013-04-03.

mild assessed

Grade 3 neutropenia with onset in cycle 2 (2013-03-04); assessed as related to study drug (probable); resolved 2013-03-11; action: drug interrupted.

severe assessed

Grade 1 vomiting with onset in cycle 2 (2013-02-27); assessed as not related to study drug (not related); resolved 2013-03-01.

mild assessed

Grade 1 blood alkaline phosphatase increased with onset in cycle 1 (2013-02-21); assessed as not related to study drug (unlikely); resolved 2013-03-12.

mild assessed

Grade 1 hypokalaemia with onset in cycle 1 (2013-02-18); assessed as not related to study drug (not related); resolved 2013-02-26.

mild assessed

Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-17; action: dose reduced.

severe serious assessed

Grade 1 nausea with onset in cycle 1 (2013-02-05); assessed as not related to study drug (unlikely); resolved 2013-02-10.

mild assessed

Data queries

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