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Table 6 Most Frequent Non-fatal Serious Adverse Events

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)

QTC prolongation

15

1.05

0.85 (0.48–1.41)

Suicide attempts/Other overdoses

7

0.49

0.40 (0.16–0.82)

Heart Rate Anomaly

4

0.28

0.23 (0.06–0.58)

Convulsion

4

0.28

0.23 (0.06–0.58)

Overdose of sertindole

4

0.28

0.23 (0.06–0.58)

Syncope

3

0.21

0.17 (0.04–0.50)

Carcinoma/Tumour

2

0.14

0.11 (0.01–0.41)

Other serious adverse event

48

3.35

2.73 (2.01–3.62)

Total

87

6.08

4.95 (3.96–6.10)