adverse reactions
6 ADVERSE REACTIONS The following treatment-emergent adverse events are discussed in more detail in other sections of the labeling: Respiratory Depression [see Contraindications (4.1) and Warnings and Precautions (5.1) ] CNS Depression [see Warnings and Precautions (5.2) ] Because clinical studies are conducted under widely varying conditions, adverse event rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. A treatment-emergent adverse event refers to any untoward medical event associated with the use of the drug in humans, whether or not considered drug-related. Based on data from nine Phase 2/3 studies that administered multiple doses (seven placebo- and/or active-controlled, one noncontrolled and one Phase 3 active-controlled safety study) the most common adverse events (reported by ≥10% in any NUCYNTA ® dose group) were: nausea, dizziness, vomiting and somnolence. The most common reasons for discontinuation due to adverse events in the studies described above (reported by ≥1% in any NUCYNTA ® dose group) were dizziness (2.6% vs. 0.5%), nausea (2.3% vs. 0.6%), vomiting (1.4% vs. 0.2%), somnolence (1.3% vs. 0.2%) and headache (0.9% vs. 0.2%) for NUCYNTA ® - and placebo-treated patients, respectively. Seventy-six percent of NUCYNTA ® -treated patients from the nine studies experienced adverse events. NUCYNTA ® was studied in multiple-dose, active- or placebo-controlled studies, or noncontrolled studies (n = 2178), in single-dose studies (n = 870), in open-label study extension (n = 483) and in Phase 1 studies (n = 597). Of these, 2034 patients were treated with doses of 50 mg to 100 mg of NUCYNTA ® dosed every 4 to 6 hours. The data described below reflect exposure to NUCYNTA ® in 3161 patients, including 449 exposed for 45 days. NUCYNTA ® was studied primarily in placebo- and active-controlled studies (n = 2266, and n = 2944, respectively). The population was 18 to 85 years old (mean age 46 years), 68% were female, 75% white and 67% were postoperative. Most patients received NUCYNTA ® doses of 50 mg, 75 mg, or 100 mg every 4 to 6 hours. 6.1 Commonly-Observed Treatment-Emergent Adverse Events in Double-Blind Controlled Clinical Trials