Patient
P2B-119
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 Health Centre Oncology Department (Budapest, Hungary) (Dr. Clarke)
consented 2013-05-27
Adverse events
5
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 5
Grade 1 alopecia with onset in cycle 2 (2013-07-15); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 3 hypokalaemia with onset in cycle 2 (2013-07-06); assessed as not related to study drug (unlikely); resolved 2013-07-15; action: drug withdrawn.
Grade 2 decreased appetite with onset in cycle 1 (2013-06-22); assessed as not related to study drug (not related); resolved 2013-07-17.
Grade 2 neutropenia with onset in cycle 1 (2013-06-17); assessed as related to study drug (probable); resolved 2013-06-27.
Grade 1 nausea with onset in cycle 1 (2013-06-05); assessed as not related to study drug (not related); resolved 2013-06-07.
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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