Patient
P2B-039
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 · Border Medical Oncology (Wodonga, Australia) (Dr. Kim)
consented 2012-10-10
Adverse events
9
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 9
Grade 2 alopecia with onset in cycle 4 (2013-01-15); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 asthenia with onset in cycle 4 (2013-01-04); assessed as not related to study drug (unlikely); resolved 2013-01-12.
Grade 2 decreased appetite with onset in cycle 4 (2012-12-28); assessed as not related to study drug (unlikely); resolved 2013-01-08.
Grade 2 alanine aminotransferase increased with onset in cycle 3 (2012-12-14); assessed as not related to study drug (not related); resolved 2012-12-24.
Grade 1 fatigue with onset in cycle 3 (2012-12-10); assessed as not related to study drug (unlikely); resolved 2012-12-28.
Grade 2 vomiting with onset in cycle 3 (2012-12-07); assessed as not related to study drug (unlikely); resolved 2012-12-08.
Grade 2 ejection fraction decreased with onset in cycle 2 (2012-12-04); assessed as related to study drug (probable); resolved 2013-01-28.
Grade 3 pain in extremity with onset in cycle 2 (2012-11-25); assessed as not related to study drug (not related); resolved 2012-12-15.
Grade 1 aspartate aminotransferase increased with onset in cycle 2 (2012-11-23); assessed as not related to study drug (not related); resolved 2012-12-13.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
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