Table 5.

Incidence of adverse drug reactions^†

Category	Sapropterin (N = 85)
Number of patients with adverse drug reactions	1
Number of adverse drug reactions (events)	1
Incidence of adverse drug reactions, % (95% CI)	1.2 (0.03–6.38)
SOC: Investigations, n (%)†	1 (1.2)
PT: Alanine aminotransferase increased	1 (1.2)

^†SOC was used to calculate the number of patients who developed adverse drug reactions; PT was used to calculate the number of patients who developed adverse drug reactions (number of adverse drug reactions).

Adverse drug reactions were categorized per MedDRA/J Version 21.0.

CI, confidence interval; MedDRA/J, ICH Medical Dictionary for Regulatory Activities Japanese edition; PT, preferred term; SOC, System Organ Class.