Patient
P2B-100
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 · Tata Memorial Hospital, Department of Medical Oncology (Mumbai, India) (Dr. Kim)
consented 2013-04-09
Adverse events
8
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 3 anaemia with onset in cycle 6 (2013-08-22); assessed as related to study drug (probable); resolved 2013-09-23.
Grade 2 nausea with onset in cycle 6 (2013-08-09); assessed as not related to study drug (not related); resolved 2013-08-13.
Grade 2 alopecia with onset in cycle 5 (2013-08-04); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 leukopenia with onset in cycle 5 (2013-07-27); assessed as related to study drug (probable); resolved 2013-08-05.
Grade 1 decreased appetite with onset in cycle 4 (2013-07-11); assessed as not related to study drug (unlikely); resolved 2013-07-28.
Grade 1 weight decreased with onset in cycle 2 (2013-05-22); assessed as not related to study drug (unlikely); resolved 2013-06-17.
Grade 1 cough with onset in cycle 1 (2013-05-02); assessed as not related to study drug (unlikely); resolved 2013-05-31.
Grade 1 fatigue with onset in cycle 1 (2013-04-27); assessed as not related to study drug (unlikely); resolved 2013-05-24.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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