Patient
P2B-118
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 2013-05-25
Adverse events
7
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 7
Grade 3 anaemia with onset in cycle 6 (2013-10-07); assessed as related to study drug (probable); resolved 2013-10-21; action: drug interrupted.
Grade 2 alopecia with onset in cycle 6 (2013-10-06); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 3 leukopenia with onset in cycle 5 (2013-09-10); assessed as related to study drug (probable); resolved 2013-09-16.
Grade 1 pyrexia with onset in cycle 5 (2013-09-07); assessed as not related to study drug (unlikely); resolved 2013-09-09.
Grade 2 vomiting with onset in cycle 5 (2013-08-31); assessed as not related to study drug (not related); resolved 2013-09-02.
Grade 1 diarrhoea with onset in cycle 4 (2013-08-20); assessed as not related to study drug (not related); resolved 2013-08-24.
Grade 2 stomatitis with onset in cycle 2 (2013-07-07); assessed as related to study drug (probable); resolved 2013-07-13.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
This participant doesn't use Luna
Invite them from the site to track mood, adherence and check-ins.