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Table 5 Overall summary of adverse events—Safety extension population

From: Long-term efficacy and safety of sapropterin in patients who initiated sapropterin at < 4 years of age with phenylketonuria: results of the 3-year extension of the SPARK open-label, multicentre, randomised phase IIIb trial

 

‘sapropterin continuous’ (n = 25)

‘sapropterin extension’ (n = 26)

Overall (N = 51)

Patients n (%)

Events n (%)

Patients n (%)

Events n (%)

Patients n (%)

Events n (%)

TEAEs

25 (100)

838 (100)

24 (92.3)

563 (100)

49 (96.1)

1401 (100)

AEs related to sapropterin

9 (36.0)

40 (4.8)

4 (15.4)

7 (1.2)

13 (25.5)

47 (3.4)

SAE

6 (24.0)

12 (1.4)

7 (26.9)

7 (1.2)

13 (25.5)

19 (1.4)

  1. AE adverse event, SAE serious adverse event, TEAE treatment-emergent adverse event