State Health Centre Oncology Department (Budapest, Hungary) › P2B-017

P2B-017

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 2012-07-09

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 1 diarrhoea with onset in cycle 2 (2012-08-28); assessed as not related to study drug (not related); resolved 2012-08-30.

mild assessed

Grade 3 anaemia with onset in cycle 2 (2012-08-22); assessed as related to study drug (probable); resolved 2012-09-19; action: drug interrupted.

severe assessed

Grade 1 alanine aminotransferase increased with onset in cycle 1 (2012-08-18); assessed as not related to study drug (not related); resolved 2012-08-25.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2012-08-17); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 1 mucosal inflammation with onset in cycle 1 (2012-08-04); assessed as related to study drug (probable); resolved 2012-08-11.

mild assessed

Grade 2 stomatitis with onset in cycle 1 (2012-08-03); assessed as related to study drug (probable); resolved 2012-08-11.

moderate assessed

Grade 3 cellulitis with onset in cycle 1 (2012-07-30); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-08-11; action: drug interrupted.

severe serious assessed

Data queries

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