Patient
P2B-124
withdrawn Phase IIA Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to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 2013-06-14
Adverse events
6
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 6
Grade 2 mucosal inflammation with onset in cycle 2 (2013-07-21); assessed as related to study drug (probable); resolved 2013-07-29.
Grade 2 asthenia with onset in cycle 2 (2013-07-20); assessed as not related to study drug (not related); resolved 2013-08-19.
Grade 3 fatigue with onset in cycle 2 (2013-07-16); assessed as not related to study drug (unlikely); resolved 2013-07-26; action: drug interrupted.
Grade 1 alopecia with onset in cycle 1 (2013-07-12); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 diarrhoea with onset in cycle 1 (2013-07-04); assessed as not related to study drug (unlikely); resolved 2013-07-09.
Grade 1 nausea with onset in cycle 1 (2013-06-24); assessed as not related to study drug (unlikely); resolved 2013-06-29.
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.