Patient
P2B-110
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 · Royal Hobart Hospital (Hobart, Australia) (Dr. Novak)
consented 2013-05-09
Adverse events
9
Serious AEs
3
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 9
Grade 3 leukopenia with onset in cycle 6 (2013-09-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-30.
Grade 2 febrile neutropenia with onset in cycle 6 (2013-09-20); assessed as related to study drug (probable); resolved 2013-09-27.
Grade 2 anaemia with onset in cycle 4 (2013-08-17); assessed as related to study drug (probable); resolved 2013-08-28.
Grade 3 pulmonary embolism with onset in cycle 4 (2013-08-16); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-09-04; action: drug interrupted.
Grade 1 fatigue with onset in cycle 4 (2013-08-11); assessed as not related to study drug (not related); resolved 2013-09-04.
Grade 3 neutropenia with onset in cycle 1 (2013-06-05); assessed as related to study drug (probable); resolved 2013-06-13; action: drug interrupted.
Grade 3 febrile neutropenia with onset in cycle 1 (2013-06-03); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-12; action: dose reduced.
Grade 2 leukopenia with onset in cycle 1 (2013-06-02); assessed as related to study drug (probable); resolved 2013-06-10.
Grade 3 stomatitis with onset in cycle 1 (2013-06-02); assessed as related to study drug (probable); resolved 2013-06-07; action: drug interrupted.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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