Patient
P2B-112
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 2013-05-12
Adverse events
9
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 9
Grade 3 anaemia with onset in cycle 6 (2013-09-26); assessed as related to study drug (probable); resolved 2013-10-10; action: drug interrupted.
Grade 2 cough with onset in cycle 5 (2013-08-23); assessed as not related to study drug (unlikely); resolved 2013-09-17.
Grade 1 constipation with onset in cycle 5 (2013-08-22); assessed as not related to study drug (unlikely); resolved 2013-08-28.
Grade 1 dyspnoea with onset in cycle 3 (2013-07-25); assessed as not related to study drug (unlikely); resolved 2013-08-13.
Grade 2 asthenia with onset in cycle 3 (2013-07-24); assessed as not related to study drug (not related); resolved 2013-08-05.
Grade 1 mucosal inflammation with onset in cycle 3 (2013-07-19); assessed as related to study drug (probable); resolved 2013-07-28.
Grade 1 weight decreased with onset in cycle 2 (2013-07-05); assessed as not related to study drug (unlikely); resolved 2013-08-22.
Grade 1 pyrexia with onset in cycle 2 (2013-06-24); assessed as not related to study drug (unlikely); resolved 2013-06-28.
Grade 1 stomatitis with onset in cycle 1 (2013-06-07); assessed as related to study drug (probable); resolved 2013-06-13.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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