Patient
P2B-017
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 Health Centre Oncology Department (Budapest, Hungary) (Dr. Clarke)
consented 2012-07-09
Adverse events
7
Serious AEs
1
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 7
Grade 1 diarrhoea with onset in cycle 2 (2012-08-28); assessed as not related to study drug (not related); resolved 2012-08-30.
Grade 3 anaemia with onset in cycle 2 (2012-08-22); assessed as related to study drug (probable); resolved 2012-09-19; action: drug interrupted.
Grade 1 alanine aminotransferase increased with onset in cycle 1 (2012-08-18); assessed as not related to study drug (not related); resolved 2012-08-25.
Grade 2 alopecia with onset in cycle 1 (2012-08-17); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 1 mucosal inflammation with onset in cycle 1 (2012-08-04); assessed as related to study drug (probable); resolved 2012-08-11.
Grade 2 stomatitis with onset in cycle 1 (2012-08-03); assessed as related to study drug (probable); resolved 2012-08-11.
Grade 3 cellulitis with onset in cycle 1 (2012-07-30); serious (hospitalization); assessed as related to study drug (possible); resolved 2012-08-11; action: drug interrupted.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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