The primary safety assessment of SUNLENCA was based on data from heavily treatment-experienced adult subjects with HIV who received SUNLENCA in a Phase 2/3 trial (CAPELLA; N=72) through Week 52 (median duration on study of 71 weeks) [see Clinical Studies (14)] , as well as supportive data in treatment-naïve adult subjects with HIV who received SUNLENCA in a Phase 2 trial (CALIBRATE; n = 157)到第54周(暴露的中位持续时间为66周)。在Capella中至少有3%的受试者中报告的最常见的不良反应(所有等级)是恶心和注射部位反应。无论严重程度如何,由于不良事件而停止使用Sunlenca治疗的Capella的受试者的比例为1%(1级注射部位结节1受试者)。表3显示了Sunlenca组大于或等于3%的不良反应的频率。
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