State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine) › P2B-131

P2B-131

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 Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine) · Dr. Nolan
consented 2013-07-09

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 hypokalaemia with onset in cycle 2 (2013-08-15); assessed as not related to study drug (unlikely); resolved 2013-08-15; action: drug withdrawn.

severe assessed

Grade 2 oedema peripheral with onset in cycle 1 (2013-08-05); assessed as not related to study drug (not related); resolved 2013-09-03.

moderate assessed

Grade 2 thrombocytopenia with onset in cycle 1 (2013-07-29); assessed as related to study drug (probable); resolved 2013-08-05.

moderate assessed

Grade 1 anaemia with onset in cycle 1 (2013-07-28); assessed as related to study drug (probable); resolved 2013-08-11.

mild assessed

Grade 1 fatigue with onset in cycle 1 (2013-07-24); assessed as not related to study drug (not related); resolved 2013-08-05.

mild assessed

Data queries

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