Table 5.

Summary of adverse events, serious adverse events and adverse events leading to discontinuationa

	2 mg kg –1 b.i.d.			2 mg kg –1 t.i.d.
	<2 years n = 10	≥2 years n = 23	Overall n = 33	<2 years n = 11	≥2 years n = 20	Overall n = 31
Treatment exposure, weeks, mean ± SD	22.8 ± 6.0	24.0 ± 2.2	23.6 ± 3.7	21.8 ± 8.3	24.1 ± 1.4	23.3 ± 5.0
Patients with ≥1 AE, n (%)	6 (60.0)	16 (69.6)	22 (66.7)	8 (72.7)	13 (65.0)	21 (67.7)
Total no. of AEs	19	43	62	31	61	92
Patients with ≥1 SAE, n (%)	2 (20.0)	2 (8.7)	4 (12.1)	4 (36.4)	2 (10.0)	6 (19.4)
Total no. of SAEs	5	3	8	8	2	10
Patients with ≥1 AE leading to treatment discontinuation, n (%)	1 (10.0)	1 (4.3)	2 (6.1)	1 (9.1)	–	1 (3.2)
No. of AEs leading to treatment discontinuation	1	1	2	2b	–	2b

^aUp to end of treatment +7 days; all‐treated set

^bOne patient experienced two separate AEs leading to treatment discontinuation (PAH worsening and bronchopneumonia)

AE, adverse event; b.i.d., twice daily; PAH, pulmonary arterial hypertension; SAE: serious adverse event; SD, standard deviation; t.i.d., three times daily