SUSARforExpeditedReportingPPT.pptVIP

What Should be Reported ? Single cases of serious, unexpected ADRs Related + Serious + unexpected →Suspected Unexpected Serious Adverse Reaction An increased in the rate of occurrence for an expected, serious ADR  通常sponsor才知道 A significant harzard to the patient population 例如期間分析發現無療效 A major safety finding from a newly completed animal study 例如降血糖藥GLP-1 agonist 和 c-cell neoplasia and medullary thyroid carcinoma in rats Active comparator的SUSAR 仍須快速通報 在盲性試驗中如何判讀： 盡量在維持盲性的狀態下評估。 必要時(例如對治療有決定性因素時)可以單一病例解盲。 無法確定expectedness時，皆視為unexpected 舉例 某癌症病患接受一已上市化療藥物治療，發生白血球降低至1500/mm3，住院接受反隔離和治療。→ R