Patient
P2B-051
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 · Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India) (Dr. Ito)
consented 2012-11-06
Adverse events
4
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 4
Grade 1 hypoalbuminaemia with onset in cycle 4 (2013-02-06); assessed as not related to study drug (not related); resolved 2013-03-10.
Grade 3 hypokalaemia with onset in cycle 4 (2013-02-02); assessed as not related to study drug (unlikely); resolved 2013-02-07; action: drug interrupted.
Grade 1 decreased appetite with onset in cycle 2 (2012-12-19); assessed as not related to study drug (not related); resolved 2012-12-31.
Grade 1 nausea with onset in cycle 2 (2012-12-13); assessed as not related to study drug (unlikely); resolved 2012-12-15.
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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