Patient
P2B-010
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 2012-06-13
Adverse events
4
Serious AEs
1
Open data queries
2
Luna dropout signal
—
not on Luna
Adverse events 4
Grade 1 decreased appetite with onset in cycle 5 (2012-10-07); assessed as not related to study drug (not related); resolved 2012-10-29.
Grade 1 stomatitis with onset in cycle 5 (2012-09-25); assessed as related to study drug (probable); resolved 2012-10-02.
Grade 2 anaemia with onset in cycle 3 (2012-08-16); assessed as related to study drug (probable); resolved 2012-09-02.
Grade 3 leukocytosis with onset in cycle 2 (2012-07-22); serious (hospitalization); assessed as not related to study drug (unlikely); resolved 2012-07-27; action: dose reduced.
Data queries 2
Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-010 occurred on 2012-10-13, 9 d late against planned day 106 (2012-10-04 ± 3 d, anchored on first dose 2012-06-21). 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-010 occurred on 2012-09-21, 8 d late against planned day 85 (2012-09-13 ± 3 d, anchored on first dose 2012-06-21). 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.