Patient
P2B-077
withdrawn Phase IIA Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to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 · Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel (Dnipropetrovsk, Ukraine) (Dr. Reyes)
consented 2013-02-17
Adverse events
5
Serious AEs
0
Open data queries
1
Luna dropout signal
—
not on Luna
Adverse events 5
Grade 1 fatigue with onset in cycle 4 (2013-05-24); assessed as not related to study drug (not related); resolved 2013-06-09.
Grade 2 anaemia with onset in cycle 3 (2013-04-29); assessed as related to study drug (probable); resolved 2013-05-21.
Grade 1 mucosal inflammation with onset in cycle 2 (2013-04-10); assessed as related to study drug (probable); resolved 2013-04-17.
Grade 2 thrombocytopenia with onset in cycle 2 (2013-04-06); assessed as related to study drug (probable); resolved 2013-04-18.
Grade 3 neutropenia with onset in cycle 1 (2013-03-18); assessed as related to study drug (probable); resolved 2013-03-24.
Data queries 1
Visit Cycle 4 Day 1: infusion (V5) for P2B-077 occurred on 2013-05-17, 5 d late against planned day 64 (2013-05-12 ± 3 d, anchored on first dose 2013-03-10). Confirm the visit date or record a protocol deviation.
Luna engagement
This participant doesn't use Luna
Invite them from the site to track mood, adherence and check-ins.