Patient
P2B-102
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 · CTRC Institute for Drug Development, University of Texas (San Antonio, TX) (Dr. Muller)
consented 2013-04-18
Adverse events
8
Serious AEs
2
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 1 anaemia with onset in cycle 4 (2013-07-26); assessed as related to study drug (probable); resolved 2013-08-05.
Grade 3 anaemia with onset in cycle 4 (2013-07-16); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-07-23; action: drug withdrawn.
Grade 2 asthenia with onset in cycle 4 (2013-07-16); assessed as not related to study drug (not related); resolved 2013-08-09.
Grade 2 vomiting with onset in cycle 3 (2013-06-23); assessed as not related to study drug (unlikely); resolved 2013-06-25.
Grade 1 nausea with onset in cycle 3 (2013-06-22); assessed as not related to study drug (not related); resolved 2013-06-23.
Grade 2 febrile neutropenia with onset in cycle 2 (2013-06-10); assessed as related to study drug (probable); resolved 2013-06-15.
Grade 1 alopecia with onset in cycle 1 (2013-05-27); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 3 febrile neutropenia with onset in cycle 1 (2013-05-22); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-05-28; action: drug interrupted.
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.