Patient
P2B-104
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 · Sarcoma Oncology Center (Santa Monica, CA) (Dr. Reyes)
consented 2013-04-25
Adverse events
8
Serious AEs
1
Open data queries
1
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 1 nausea with onset in cycle 6 (2013-08-31); assessed as not related to study drug (not related); resolved 2013-09-05.
Grade 2 stomatitis with onset in cycle 5 (2013-08-17); assessed as related to study drug (probable); resolved 2013-08-26.
Grade 4 neutropenia with onset in cycle 5 (2013-08-12); assessed as related to study drug (probable); resolved 2013-08-17; action: drug interrupted.
Grade 3 vomiting with onset in cycle 5 (2013-08-10); serious (hospitalization); assessed as related to study drug (possible); resolved 2013-08-13; action: drug interrupted.
Grade 2 anaemia with onset in cycle 4 (2013-07-27); assessed as related to study drug (probable); resolved 2013-08-24.
Grade 1 vomiting with onset in cycle 4 (2013-07-18); assessed as not related to study drug (unlikely); resolved 2013-07-19.
Grade 1 cough with onset in cycle 2 (2013-06-18); assessed as not related to study drug (not related); resolved 2013-06-25.
Grade 2 pyrexia with onset in cycle 1 (2013-05-19); assessed as not related to study drug (unlikely); resolved 2013-05-22.
Data queries 1
AE Neutropenia (grade 4) for P2B-104 (onset 2013-08-12) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.
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