Patient
P2B-064
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 · Jehangir Clinical Development Centre Pvt Ltd (Pune, India) (Dr. Tanaka)
consented 2012-12-23
Adverse events
6
Serious AEs
1
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 6
Grade 2 asthenia with onset in cycle 5 (2013-04-21); assessed as related to study drug (possible); resolved 2013-05-16.
Grade 1 cough with onset in cycle 5 (2013-04-17); assessed as not related to study drug (unlikely); resolved 2013-05-04.
Grade 2 pyrexia with onset in cycle 5 (2013-04-14); assessed as not related to study drug (not related); resolved 2013-04-16.
Grade 1 weight decreased with onset in cycle 5 (2013-04-10); assessed as not related to study drug (unlikely); resolved 2013-05-05.
Grade 1 abdominal pain with onset in cycle 5 (2013-04-05); assessed as not related to study drug (unlikely); resolved 2013-04-12.
Grade 3 pyrexia with onset in cycle 4 (2013-03-25); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-03-28.
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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