Patient
P2B-090
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 · Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia) (Dr. Dubois)
consented 2013-03-21
Adverse events
7
Serious AEs
1
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 7
Grade 1 anaemia with onset in cycle 5 (2013-07-19); assessed as related to study drug (probable); resolved 2013-08-14.
Grade 1 nausea with onset in cycle 5 (2013-07-04); assessed as not related to study drug (unlikely); resolved 2013-07-07.
Grade 1 fatigue with onset in cycle 4 (2013-06-27); assessed as not related to study drug (unlikely); resolved 2013-07-08.
Grade 3 febrile neutropenia with onset in cycle 4 (2013-06-14); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-06-22.
Grade 1 thrombocytopenia with onset in cycle 2 (2013-05-06); assessed as related to study drug (probable); resolved 2013-05-18.
Grade 2 febrile neutropenia with onset in cycle 1 (2013-04-19); assessed as related to study drug (probable); resolved 2013-04-24.
Grade 1 neutropenia with onset in cycle 1 (2013-04-14); assessed as related to study drug (probable); resolved 2013-04-23.
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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