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searching for a compound and subsequently downloading its safety data set.
We analyzed the AEs in the safety data set.
The primary efficacy analysis was based on the safety data set and was considered confirmatory.
Of the 230 patients enrolled in the study, 229 were treated (the patient excluded from the safety data set had no treatment data and no adverse reactions reported).
The safety data set included all patients who took at least one capsule of controlled-release flecainide acetate after study inclusion.
Demographic and main baseline characteristics of the safety data set according to symptomatic PAF control at inclusion are summarized in Table 1.
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Since no single "gold standard" ADE data set exists, a range of different drug safety data sets are currently used for developing ADE prediction models.
However, systematic comparisons of the major safety data sets used in system pharmacological models and assessment of the impact of data-set choice on prediction performance are lacking.
In summary, we have conducted a study that systematically compared two drug safety data sets and assessed the impact of data set choice on the prediction performance of the PPN predictive model.
The results of this analysis also highlight the importance of large safety data sets and ongoing postmarketing surveillance of licensed and approved medications to identify side effects which might otherwise be dismissed as complications of the underlying disease in a patient group with significant comorbidity.
Ward patient safety scores in the data set varied by as much as 28,7 points, from a low of 52.7 to a high of 81.3.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com