Patient
P2B-103
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 · Medisprof SRL (Cluj-Napoca, Romania) (Dr. Kowalski)
consented 2013-04-23
Adverse events
8
Serious AEs
0
Open data queries
0
Luna dropout signal
—
not on Luna
Adverse events 8
Grade 2 vomiting with onset in cycle 6 (2013-08-17); assessed as not related to study drug (not related); resolved 2013-08-20.
Grade 2 alopecia with onset in cycle 5 (2013-08-07); assessed as related to study drug (probable); not resolved at last follow-up.
Grade 2 anaemia with onset in cycle 5 (2013-08-07); assessed as related to study drug (probable); resolved 2013-08-22.
Grade 1 oedema peripheral with onset in cycle 5 (2013-08-04); assessed as not related to study drug (unlikely); resolved 2013-09-06.
Grade 2 diarrhoea with onset in cycle 5 (2013-08-01); assessed as not related to study drug (not related); resolved 2013-08-05.
Grade 2 hypocalcaemia with onset in cycle 4 (2013-07-21); assessed as not related to study drug (unlikely); resolved 2013-07-26.
Grade 1 fatigue with onset in cycle 4 (2013-07-20); assessed as not related to study drug (unlikely); resolved 2013-07-30.
Grade 3 pain in extremity with onset in cycle 2 (2013-06-09); assessed as not related to study drug (not related); resolved 2013-06-28.
Data queries 0
No data queries
The CDM sweep raises queries on inconsistent fields.
Luna engagement
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