Patient
P2B-026
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 · Noble Hospital Clinical Research Department 1st Floor (Hadapsar, India) (Dr. Rossi)
consented 2012-08-09
Adverse events
6
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 6
Grade 2 fatigue with onset in cycle 6 (2012-12-14); assessed as not related to study drug (unlikely); resolved 2013-01-13.
Grade 2 hypokalaemia with onset in cycle 6 (2012-12-14); assessed as not related to study drug (unlikely); resolved 2012-12-28.
Grade 2 neutropenia with onset in cycle 5 (2012-11-28); assessed as related to study drug (probable); resolved 2012-12-06.
Grade 1 aspartate aminotransferase increased with onset in cycle 4 (2012-10-29); assessed as not related to study drug (not related); resolved 2012-11-17.
Grade 2 alopecia with onset in cycle 1 (2012-09-10); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 3 thrombocytopenia with onset in cycle 1 (2012-09-07); assessed as related to study drug (probable); resolved 2012-09-16; action: drug interrupted.
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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