Skip to main content

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
Back to article page

Orphanet Journal of Rare Diseases

ISSN: 1750-1172