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We examined incidents reported between the third quarter of 2020 and the second quarter of 2023. The imbalance of risdiplam-related AEs was evaluated by computing the reporting odds ratio. A total of 5,406,334 reports were thoroughly reviewed. By removing duplicate reports, we identified 1588 reports in which risdiplam was the main suspected drug whose use was accompanied by 3470 associated AEs. Among the included AEs, 703 were categorized as serious and 885 as non-serious. Risdiplam use induced AEs across 18 organ systems, resulting in 130 positive signals.
Table 1 counts the demographic information related to risdiplam;
List of Abbreviations: DEMO, patient demographics; DRUG, administration drug details; REAC, records of adverse events.
Table 2 summarizes the RORs and confidence intervals of the adverse ev...
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Facebook
Twitterhttps://doi.org/10.5061/dryad.573n5tbfv
We examined incidents reported between the third quarter of 2020 and the second quarter of 2023. The imbalance of risdiplam-related AEs was evaluated by computing the reporting odds ratio. A total of 5,406,334 reports were thoroughly reviewed. By removing duplicate reports, we identified 1588 reports in which risdiplam was the main suspected drug whose use was accompanied by 3470 associated AEs. Among the included AEs, 703 were categorized as serious and 885 as non-serious. Risdiplam use induced AEs across 18 organ systems, resulting in 130 positive signals.
Table 1 counts the demographic information related to risdiplam;
List of Abbreviations: DEMO, patient demographics; DRUG, administration drug details; REAC, records of adverse events.
Table 2 summarizes the RORs and confidence intervals of the adverse ev...