Patient
P2B-018
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 · Blokhin Cancer Research Center (Moscow, Russia) (Dr. Moreau)
consented 2012-07-12
Adverse events
8
Serious AEs
1
Open data queries
4
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 2 hypoalbuminaemia with onset in cycle 6 (2012-11-21); assessed as not related to study drug (not related); resolved 2012-12-23.
Grade 1 hypocalcaemia with onset in cycle 5 (2012-11-03); assessed as not related to study drug (unlikely); resolved 2012-11-23.
Grade 2 weight decreased with onset in cycle 5 (2012-11-01); assessed as not related to study drug (unlikely); resolved 2012-12-17.
Grade 3 diarrhoea with onset in cycle 3 (2012-09-22); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-09-24; action: drug interrupted.
Grade 2 fatigue with onset in cycle 2 (2012-08-30); assessed as not related to study drug (not related); resolved 2012-09-13.
Grade 2 hypokalaemia with onset in cycle 2 (2012-08-27); assessed as not related to study drug (unlikely); resolved 2012-08-30.
Grade 2 alopecia with onset in cycle 1 (2012-08-16); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 diarrhoea with onset in cycle 1 (2012-08-08); assessed as not related to study drug (unlikely); resolved 2012-08-14.
Data queries 4
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-018 occurred on 2012-11-18, 4 d late against planned day 106 (2012-11-14 ± 3 d, anchored on first dose 2012-08-01). 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-018 occurred on 2012-10-29, 5 d late against planned day 85 (2012-10-24 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.
Visit Cycle 4 Day 1: infusion (V5) for P2B-018 occurred on 2012-10-08, 5 d late against planned day 64 (2012-10-03 ± 3 d, anchored on first dose 2012-08-01). 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-018 occurred on 2012-09-17, 5 d late against planned day 43 (2012-09-12 ± 3 d, anchored on first dose 2012-08-01). Confirm the visit date or record a protocol deviation.
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