Patient
P2B-075
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 · The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia) (Dr. Kowalski)
consented 2013-02-04
Adverse events
8
Serious AEs
4
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 3 neutropenia with onset in cycle 1 (2013-02-28); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 3 stomatitis with onset in cycle 1 (2013-02-28); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 1 thrombocytopenia with onset in cycle 1 (2013-02-28); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 febrile neutropenia with onset in cycle 1 (2013-02-27); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 5 septic shock with onset in cycle 1 (2013-02-27); serious (death; life-threatening; hospitalization); assessed as related to study drug (probable); fatal outcome on 2013-03-01.
Grade 2 stomatitis with onset in cycle 1 (2013-02-27); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 4 febrile neutropenia with onset in cycle 1 (2013-02-26); serious (hospitalization); assessed as related to study drug (probable); not resolved at last follow-up; action: drug interrupted.
Grade 3 dehydration with onset in cycle 1 (2013-02-25); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-02-28.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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