Patient
P2B-081
withdrawn Phase IIA Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to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 · Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia) (Dr. Dubois)
consented 2013-02-28
Adverse events
5
Serious AEs
0
Open data queries
1
Luna dropout signal
—
not on Luna
Adverse events 5
Grade 1 decreased appetite with onset in cycle 2 (2013-04-03); assessed as not related to study drug (unlikely); resolved 2013-04-21.
Grade 4 thrombocytopenia with onset in cycle 1 (2013-03-22); assessed as related to study drug (probable); resolved 2013-03-28.
Grade 2 stomatitis with onset in cycle 1 (2013-03-20); assessed as related to study drug (probable); resolved 2013-03-28.
Grade 1 hypoalbuminaemia with onset in cycle 1 (2013-03-17); assessed as not related to study drug (unlikely); resolved 2013-04-16.
Grade 1 abdominal pain with onset in cycle 1 (2013-03-16); assessed as not related to study drug (not related); resolved 2013-03-26.
Data queries 1
AE Thrombocytopenia (grade 4) for P2B-081 (onset 2013-03-22) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
Luna engagement
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