State Health Centre Oncology Department (Budapest, Hungary) › P2B-108

P2B-108

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 2013-05-01

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 anaemia with onset in cycle 4 (2013-07-30); assessed as related to study drug (probable); resolved 2013-09-08.

mild assessed

Grade 1 neutropenia with onset in cycle 3 (2013-06-28); assessed as related to study drug (probable); resolved 2013-07-03.

mild assessed

Grade 3 thrombocytopenia with onset in cycle 2 (2013-06-10); assessed as related to study drug (probable); resolved 2013-06-15.

severe assessed

Grade 1 nausea with onset in cycle 2 (2013-06-01); assessed as not related to study drug (not related); resolved 2013-06-04.

mild assessed

Grade 3 leukopenia with onset in cycle 1 (2013-05-24); assessed as related to study drug (probable); resolved 2013-05-29; action: drug interrupted.

severe assessed

Grade 3 pleurisy with onset in cycle 1 (2013-05-19); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-05-29; action: drug interrupted.

severe serious assessed

Data queries

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