MARQIBO adverse reactions
Most commonly reported (>5%) Grade 3 or greater adverse reactions among 83 patients receiving the clinical
* National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
† Study 2 was a phase 1 study that included 18 patients treated at the MARQIBO recommended dose of 2.25 mg/m2 intravenously over 1 hour every 7 days.
‡ Including neuropathy-associated adverse events.
- Adverse reactions were observed in 100% of patients
- Dose reduction, delay, or omission occurred in 53% of patients during the treatment
- Adverse reactions related to neuropathy and leading to treatment discontinuation were decreased vibratory sense, facial palsy, hyporeflexia, constipation, asthenia, fatigue, and musculoskeletal pain, each reported in at least one patient
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- The most commonly reported adverse reactions (incidence >30%) in clinical studies include constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%)
- A total of 75.9% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included febrile neutropenia (20.5%), pyrexia (13.3%), hypotension (7.2%), respiratory distress (6.0%), and cardiac arrest (6.0%)