Patient
P2B-083
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 · Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania) (Dr. Silva)
consented 2013-03-02
Adverse events
8
Serious AEs
1
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 3 anaemia with onset in cycle 5 (2013-06-21); assessed as related to study drug (probable); resolved 2013-07-28; action: drug interrupted.
Grade 2 nausea with onset in cycle 5 (2013-06-10); assessed as not related to study drug (unlikely); resolved 2013-06-15.
Grade 2 pain in extremity with onset in cycle 4 (2013-06-05); assessed as not related to study drug (not related); resolved 2013-07-04.
Grade 2 hypocalcaemia with onset in cycle 3 (2013-05-16); assessed as not related to study drug (not related); resolved 2013-05-22.
Grade 1 stomatitis with onset in cycle 2 (2013-04-15); assessed as related to study drug (probable); resolved 2013-04-20.
Grade 3 neutropenia with onset in cycle 2 (2013-04-12); assessed as related to study drug (probable); resolved 2013-04-18.
Grade 3 cellulitis with onset in cycle 2 (2013-04-09); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-04-20; action: drug interrupted.
Grade 1 blood alkaline phosphatase increased with onset in cycle 1 (2013-04-04); assessed as not related to study drug (not related); resolved 2013-04-22.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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