P2B-038

State Health Centre Oncology Department (Budapest, Hungary) › P2B-038

P2B-038

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 2012-09-27

withdrawn

AEs

3

Serious

0

Dropout signal

–

Adverse events

3

Grade 1 weight decreased with onset in cycle 2 (2012-11-11); assessed as not related to study drug (unlikely); resolved 2012-12-24.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2012-10-24); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 1 stomatitis with onset in cycle 1 (2012-10-15); assessed as related to study drug (probable); resolved 2012-10-26.

mild assessed

Data queries

0

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