Patient
P2B-089
completed Phase IIA 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 · Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) (Dr. Okafor)
consented 2013-03-18
Adverse events
6
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 6
Grade 1 leukopenia with onset in cycle 4 (2013-06-22); assessed as related to study drug (probable); resolved 2013-07-02.
Grade 3 neutropenia with onset in cycle 4 (2013-06-19); assessed as related to study drug (probable); resolved 2013-06-29.
Grade 1 vomiting with onset in cycle 3 (2013-05-24); assessed as not related to study drug (not related); resolved 2013-05-25.
Grade 1 aspartate aminotransferase increased with onset in cycle 2 (2013-05-02); assessed as not related to study drug (unlikely); resolved 2013-05-21.
Grade 2 decreased appetite with onset in cycle 2 (2013-05-01); assessed as not related to study drug (not related); resolved 2013-05-11.
Grade 2 nausea with onset in cycle 2 (2013-05-01); assessed as not related to study drug (not related); resolved 2013-05-02.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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