State Health Centre Oncology Department (Budapest, Hungary) › P2B-119

P2B-119

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 2013-05-27

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 alopecia with onset in cycle 2 (2013-07-15); assessed as related to study drug (probable); not resolved at last follow-up.

mild assessed

Grade 3 hypokalaemia with onset in cycle 2 (2013-07-06); assessed as not related to study drug (unlikely); resolved 2013-07-15; action: drug withdrawn.

severe assessed

Grade 2 decreased appetite with onset in cycle 1 (2013-06-22); assessed as not related to study drug (not related); resolved 2013-07-17.

moderate assessed

Grade 2 neutropenia with onset in cycle 1 (2013-06-17); assessed as related to study drug (probable); resolved 2013-06-27.

moderate assessed

Grade 1 nausea with onset in cycle 1 (2013-06-05); assessed as not related to study drug (not related); resolved 2013-06-07.

mild assessed

Data queries

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