Patient
P2B-052
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 · Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania) (Dr. Novak)
consented 2012-11-21
Adverse events
9
Serious AEs
2
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 9
Grade 2 stomatitis with onset in cycle 6 (2013-03-25); assessed as related to study drug (probable); resolved 2013-04-01.
Grade 3 febrile neutropenia with onset in cycle 2 (2013-01-03); assessed as related to study drug (probable); resolved 2013-01-10; action: drug interrupted.
Grade 1 neutropenia with onset in cycle 2 (2013-01-02); assessed as related to study drug (probable); resolved 2013-01-11.
Grade 2 mucosal inflammation with onset in cycle 2 (2012-12-31); assessed as related to study drug (probable); resolved 2013-01-09.
Grade 2 vomiting with onset in cycle 2 (2012-12-23); assessed as not related to study drug (unlikely); resolved 2012-12-25.
Grade 3 neutropenia with onset in cycle 1 (2012-12-11); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-20; action: dose reduced.
Grade 2 leukopenia with onset in cycle 1 (2012-12-08); assessed as related to study drug (probable); resolved 2012-12-17.
Grade 1 pyrexia with onset in cycle 1 (2012-12-07); assessed as not related to study drug (unlikely); resolved 2012-12-08.
Grade 3 stomatitis with onset in cycle 1 (2012-12-04); serious (hospitalization); assessed as related to study drug (probable); resolved 2012-12-10; action: drug interrupted.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
This participant doesn't use Luna
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