Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) › P2B-129

P2B-129

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
Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) · Dr. Okafor
consented 2013-07-08

completed

AEs

Serious

Dropout signal

–

Adverse events

Grade 3 anaemia with onset in cycle 5 (2013-10-30); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-12-02; action: drug interrupted.

severe serious under_review

Grade 2 anaemia with onset in cycle 4 (2013-10-12); assessed as related to study drug (probable); resolved 2013-11-13.

moderate assessed

Grade 1 stomatitis with onset in cycle 4 (2013-10-03); assessed as related to study drug (probable); resolved 2013-10-09.

mild assessed

Grade 2 asthenia with onset in cycle 4 (2013-10-02); assessed as not related to study drug (unlikely); resolved 2013-10-29.

moderate assessed

Grade 1 thrombocytopenia with onset in cycle 3 (2013-09-17); assessed as related to study drug (probable); resolved 2013-09-27.

mild assessed

Grade 2 alopecia with onset in cycle 1 (2013-08-17); assessed as related to study drug (probable); not resolved at last follow-up.

moderate assessed

Grade 2 pain in extremity with onset in cycle 1 (2013-08-13); assessed as not related to study drug (unlikely); resolved 2013-08-26.

moderate assessed

Grade 3 thrombocytopenia with onset in cycle 1 (2013-08-06); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-17.

severe serious assessed

Data queries

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