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Development of a multivariate prediction model to identify individual case safety reports which require clinical review

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The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing world‐wide. The majority of ICSRs at the Netherlands Pharmacovigilance Centre Lareb is reviewed manually to identify… Click to show full abstract

The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing world‐wide. The majority of ICSRs at the Netherlands Pharmacovigilance Centre Lareb is reviewed manually to identify potential signal triggering reports (PSTR) or ICSRs which need further clinical assessment for other reasons.

Keywords: development multivariate; safety; individual case; case safety; safety reports

Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2022

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