Patient
P2B-085
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 · Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine) (Dr. Okafor)
consented 2013-03-08
Adverse events
6
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 6
Grade 3 neutropenia with onset in cycle 6 (2013-07-12); assessed as related to study drug (probable); resolved 2013-07-19; action: drug interrupted.
Grade 2 hypoalbuminaemia with onset in cycle 5 (2013-06-24); assessed as not related to study drug (unlikely); resolved 2013-07-12.
Grade 2 stomatitis with onset in cycle 5 (2013-06-23); assessed as related to study drug (probable); resolved 2013-06-30.
Grade 1 asthenia with onset in cycle 3 (2013-05-04); assessed as not related to study drug (not related); resolved 2013-05-21.
Grade 2 alopecia with onset in cycle 2 (2013-04-23); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 1 blood alkaline phosphatase increased with onset in cycle 2 (2013-04-20); assessed as not related to study drug (not related); resolved 2013-05-15.
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.