Patient
P2B-087
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 · State Health Centre Oncology Department (Budapest, Hungary) (Dr. Clarke)
consented 2013-03-14
Adverse events
5
Serious AEs
0
Open data queries
5
Luna dropout signal
—
not on Luna
Adverse events 5
Grade 1 anaemia with onset in cycle 6 (2013-08-01); assessed as related to study drug (probable); resolved 2013-08-21.
Grade 1 hypocalcaemia with onset in cycle 5 (2013-07-25); assessed as not related to study drug (unlikely); resolved 2013-08-08.
Grade 2 decreased appetite with onset in cycle 5 (2013-07-20); assessed as not related to study drug (not related); resolved 2013-08-18.
Grade 3 stomatitis with onset in cycle 4 (2013-06-15); assessed as related to study drug (probable); resolved 2013-06-20.
Grade 1 nausea with onset in cycle 4 (2013-06-12); assessed as not related to study drug (unlikely); resolved 2013-06-16.
Data queries 5
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-087 occurred on 2013-07-30, 21 d late against planned day 106 (2013-07-09 ± 3 d, anchored on first dose 2013-03-26). 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-087 occurred on 2013-07-10, 22 d late against planned day 85 (2013-06-18 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-087 occurred on 2013-06-08, 11 d late against planned day 64 (2013-05-28 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-087 occurred on 2013-05-17, 10 d late against planned day 43 (2013-05-07 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Visit Cycle 2 Day 1: infusion (V3) for P2B-087 occurred on 2013-04-25, 9 d late against planned day 22 (2013-04-16 ± 3 d, anchored on first dose 2013-03-26). Confirm the visit date or record a protocol deviation.
Luna engagement
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