Patient
P2B-073
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 · Stanford University (Stanford, CA) (Dr. Nolan)
consented 2013-02-02
Adverse events
4
Serious AEs
0
Open data queries
2
Luna dropout signal
—
not on Luna
Adverse events 4
Grade 2 stomatitis with onset in cycle 6 (2013-06-21); assessed as related to study drug (probable); resolved 2013-07-01.
Grade 3 anaemia with onset in cycle 5 (2013-05-30); assessed as related to study drug (probable); resolved 2013-06-23.
Grade 2 leukopenia with onset in cycle 1 (2013-03-05); assessed as related to study drug (probable); resolved 2013-03-15.
Grade 1 neutropenia with onset in cycle 1 (2013-03-03); assessed as related to study drug (probable); resolved 2013-03-13.
Data queries 2
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-073 occurred on 2013-06-15, 9 d late against planned day 106 (2013-06-06 ± 3 d, anchored on first dose 2013-02-21). Confirm the visit date or record a protocol deviation.
Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-073 occurred on 2013-05-26, 10 d late against planned day 85 (2013-05-16 ± 3 d, anchored on first dose 2013-02-21). Confirm the visit date or record a protocol deviation.
Luna engagement
This participant doesn't use Luna
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