The most common treatment-emergent adverse events (>10%) while on ALO-02 were nausea, constipation, vomiting and headache. The most common serious adverse events were acute myocardial infarction, non-cardiac chest pain, pneumonia, convulsion, and kidney stones, each of which occurred in 2 patients. A total of 237 (60%) patients discontinued from the study over the one-year study period, with 19 percent of patients reporting adverse events as the primary reason for discontinuation. The adverse events that most commonly (>2%) lead to discontinuation were nausea and constipation. The discontinuation rate was within the expected range based on similar long-term safety studies with other extended-release opioid formulations.Pfizer Inc.: Working together for a healthier world®
Pfizer Announces Top-Line Results From A Phase 3 Long-Term Safety Study Of ALO-02:
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