Patient
P2B-031
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 · Royal North Shore (St Leonards, Australia) (Dr. Rossi)
consented 2012-09-03
Adverse events
2
Serious AEs
0
Open data queries
2
Luna dropout signal
—
not on Luna
Adverse events 2
Grade 1 nausea with onset in cycle 2 (2012-10-13); assessed as not related to study drug (unlikely); resolved 2012-10-18.
Grade 2 alopecia with onset in cycle 1 (2012-10-03); assessed as related to study drug (probable); not resolved at last follow-up.
Data queries 2
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-031 occurred on 2013-01-11, 9 d late against planned day 106 (2013-01-02 ± 3 d, anchored on first dose 2012-09-19). 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-031 occurred on 2012-12-21, 9 d late against planned day 85 (2012-12-12 ± 3 d, anchored on first dose 2012-09-19). Confirm the visit date or record a protocol deviation.
Luna engagement
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