Patient
P2B-117
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 · CTRC Institute for Drug Development, University of Texas (San Antonio, TX) (Dr. Muller)
consented 2013-05-24
Adverse events
9
Serious AEs
3
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 9
Grade 2 anaemia with onset in cycle 1 (2013-06-20); assessed as related to study drug (probable); resolved 2013-07-09.
Grade 3 vomiting with onset in cycle 1 (2013-06-17); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-24; action: drug withdrawn.
Grade 2 leukopenia with onset in cycle 1 (2013-06-16); assessed as related to study drug (probable); resolved 2013-06-22.
Grade 1 stomatitis with onset in cycle 1 (2013-06-14); assessed as related to study drug (probable); resolved 2013-06-23.
Grade 3 gastrointestinal haemorrhage with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2013-06-14; action: drug interrupted.
Grade 3 leukopenia with onset in cycle 1 (2013-06-09); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-18; action: dose reduced.
Grade 1 vomiting with onset in cycle 1 (2013-06-06); assessed as not related to study drug (not related); resolved 2013-06-08.
Grade 1 cough with onset in cycle 1 (2013-06-04); assessed as not related to study drug (not related); resolved 2013-06-29.
Grade 2 nausea with onset in cycle 1 (2013-06-03); assessed as not related to study drug (unlikely); resolved 2013-06-04.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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