State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine) › P2B-061

P2B-061

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 2012-12-19

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 2 fatigue with onset in cycle 5 (2013-04-10); assessed as not related to study drug (unlikely); resolved 2013-04-24.

moderate assessed

Grade 1 anaemia with onset in cycle 2 (2013-02-09); assessed as related to study drug (probable); resolved 2013-03-21.

mild assessed

Grade 2 dyspnoea with onset in cycle 2 (2013-02-06); assessed as not related to study drug (not related); resolved 2013-03-01.

moderate assessed

Grade 3 stomatitis with onset in cycle 2 (2013-02-02); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-14; action: drug interrupted.

severe serious assessed

Grade 1 stomatitis with onset in cycle 2 (2013-01-31); assessed as related to study drug (probable); resolved 2013-02-06.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2013-01-24); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 decreased appetite with onset in cycle 1 (2013-01-11); assessed as not related to study drug (unlikely); resolved 2013-02-05.

moderate assessed

Data queries

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