Patient
P2B-074
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 Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia) (Dr. Clarke)
consented 2013-02-03
Adverse events
6
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 6
Grade 1 nausea with onset in cycle 6 (2013-06-03); assessed as not related to study drug (not related); resolved 2013-06-07.
Grade 1 hypocalcaemia with onset in cycle 4 (2013-05-10); assessed as not related to study drug (not related); resolved 2013-05-20.
Grade 2 fatigue with onset in cycle 2 (2013-03-16); assessed as not related to study drug (not related); resolved 2013-04-03.
Grade 1 blood alkaline phosphatase increased with onset in cycle 1 (2013-02-27); assessed as not related to study drug (unlikely); resolved 2013-03-19.
Grade 1 diarrhoea with onset in cycle 1 (2013-02-25); assessed as not related to study drug (unlikely); resolved 2013-02-28.
Grade 1 asthenia with onset in cycle 1 (2013-02-22); assessed as related to study drug (possible); resolved 2013-03-23.
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.