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Koselugo (selumetinib)
申请企业
ASTRAZENECA PHARMACEUTICALS LP
药品名称
Koselugo (selumetinib)
承诺描述
Characterize and evaluate the long-term safety effects and any potential for serious adverse risks of selumetinib on the growth and development of pediatric patients. Submit the complete final report and long-term follow-up data from pediatric patients enrolled on SPRINT and ongoing or completed studies of selumetinib. All patients must be evaluated for growth and development milestones annually for at least 7 years from initiation of selumetinib. Evaluations must include: growth as measured by weight, height, height velocity, height standard deviation scores (SDS), age at thelarche (females), age at adrenarche (males), age at menarche (females), and Tanner Stage progression. Descriptive statistics (including mean and standard deviation values) of onstudy data for growth velocity must be presented. Growth velocity during the trial should be compared with growth velocity at baseline (if pre-baseline data are available). Provide analyses of height and weight data that assess measures of central tendency and outlier analyses using height and weight z-scores.