Patient
P2B-061
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 · State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine) (Dr. Nolan)
consented 2012-12-19
Adverse events
7
Serious AEs
1
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 7
Grade 2 fatigue with onset in cycle 5 (2013-04-10); assessed as not related to study drug (unlikely); resolved 2013-04-24.
Grade 1 anaemia with onset in cycle 2 (2013-02-09); assessed as related to study drug (probable); resolved 2013-03-21.
Grade 2 dyspnoea with onset in cycle 2 (2013-02-06); assessed as not related to study drug (not related); resolved 2013-03-01.
Grade 3 stomatitis with onset in cycle 2 (2013-02-02); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-02-14; action: drug interrupted.
Grade 1 stomatitis with onset in cycle 2 (2013-01-31); assessed as related to study drug (probable); resolved 2013-02-06.
Grade 2 alopecia with onset in cycle 1 (2013-01-24); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 decreased appetite with onset in cycle 1 (2013-01-11); assessed as not related to study drug (unlikely); resolved 2013-02-05.
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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