Patient
P2B-078
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 · Sarcoma Oncology Center (Santa Monica, CA) (Dr. Reyes)
consented 2013-02-17
Adverse events
3
Serious AEs
0
Open data queries
2
Luna dropout signal
—
not on Luna
Adverse events 3
Grade 2 stomatitis with onset in cycle 3 (2013-05-02); assessed as related to study drug (probable); resolved 2013-05-09.
Grade 1 nausea with onset in cycle 1 (2013-03-09); assessed as not related to study drug (not related); resolved 2013-03-11.
Grade 2 vomiting with onset in cycle 1 (2013-03-08); assessed as not related to study drug (not related); resolved 2013-03-09.
Data queries 2
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-078 occurred on 2013-04-27, 10 d late against planned day 43 (2013-04-17 ± 3 d, anchored on first dose 2013-03-06). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-078 occurred on 2013-04-01, 5 d late against planned day 22 (2013-03-27 ± 3 d, anchored on first dose 2013-03-06). 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.