A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels.

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作者： Daria,Piacentino ^[1] ; Ajay,Ogirala ^[1] ; Robert,Lew ^[1] ; Gregory,Loftus ^[2] ; MaryAlice,Worden ^[1] ; Kenneth S,Koblan ^[1] ; Seth C,Hopkins ^[3]

作者单位： Sumitomo Pharma America, Inc. (Formerly Sunovion Pharmaceuticals, Inc.), 84 Waterford Drive, Marlborough, MA, 01752, USA. ^[1] Sumitomo Pharma America, Inc. (Formerly Sumitovant Biopharma Inc.), Marlborough, MA, USA. ^[2] Sumitomo Pharma America, Inc. (Formerly Sunovion Pharmaceuticals, Inc.), 84 Waterford Drive, Marlborough, MA, 01752, USA. seth.hopkins@sunovion.com. ^[3]

关键词 Adverse events Duration Lurasidone Prevalence Signal detection Ulotaront

主题词人类(Humans);比值比(Odds Ratio);患病率(Prevalence);随机对照试验(主题)(Randomized Controlled Trials as Topic);抗精神病药(Antipsychotic Agents)

DOI 10.1007/s12325-023-02695-8

PMID 37855974

发布时间 2024-07-05

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