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Table 7 Most Frequent Non-fatal Serious Adverse Events – QTc prolongation

From: The Sertindole Safety Survey: A retrospective analysis under a named patient use programme in Europe

 

Number

% of total patients

Rate/100 PYE (95% CI)

QT C prolongation

15 *

1.05

0.85 (0.48–1.41)

   "Before" group

10

0.70

0.67 (0.32–1.23)

   "After" group

3

0.21

1.15 (0.24–3.37)

  1. * Among the 15 cases, only 14 CIOMS reports (Council for International Organizations of Medical Sciences) were retrieved; the initiation date of one case was not available.