Table 4.

Most common serious adverse events in the full analysis set (those with exposure-adjusted event rates per 100 person-years of >1) broken down for subgroups receiving and not receiving dialysis at baseline (data for one patient with unknown dialysis status at baseline not shown)

	Children not on dialysis (n = 160)		Children on dialysis (n = 158)
	Patients reporting, n (%)	EAER/100 person-years (95 % CI)	Patients reporting, n (%)	EAER/100 person-years (95 % CI)
Any SAE	77 (48.1)	73.8 (63.5–85.3)	85 (53.8)	140.3 (123.5–158.8)
Peritonitis	7 (4.4)	3.2 (1.4–6.4)	25 (15.8)	20.1 (14.0–27.8)
Hypertension	2 (1.3)	1.6 (0.4–4.2)	11 (7.0)	10.6 (6.4–16.5)
Gastroenteritis	11 (6.9)	5.7 (3.1–9.5)	8 (5.1)	4.5 (1.9–8.8)
Convulsions	4 (2.5)	1.6 (0.4–4.2)	6 (3.8)	6.7 (3.5–11.7)
Diarrhea	3 (1.9)	2.0 (0.7–4.7)	5 (3.2)	3.3 (1.2–7.3)
Vomiting	1 (0.6)	0.4 (0.0–2.3)	7 (4.4)	3.9 (1.6–8.0)
Urinary tract infection	6 (3.8)	2.8 (1.1–5.9)	1 (0.6)	0.6 (0.0–3.1)
Renal failure chronic	6 (3.8)	2.4 (0.9–5.3)	1 (0.6)	0.6 (0.0–3.1)
Sepsis	4 (2.5)	1.6 (0.4–4.2)	3 (1.9)	1.7 (0.3–4.9)
Pneumonia	4 (2.5)	1.6 (0.4–4.2)	2 (1.3)	1.7 (0.3–4.9)
Pyelonephritis	4 (2.5)	1.6 (0.4–4.2)	2 (1.3)	1.7 (0.3–4.9)
Pyrexia	1 (0.6)	0.4 (0.0–2.3)	3 (1.9)	3.3 (1.2–7.3)
Medical device complication	0	0	4 (2.5)	3.3 (1.2–7.3)
Bronchitis	4 (2.5)	1.6 (0.4–4.2)	2 (1.3)	1.1 (0.1–4.0)
Catheter site infection	0	0	6 (3.8)	3.3 (1.2–7.3)
Device-related infection	0	0	6 (3.8)	3.3 (1.2–7.3)
Dehydration	4 (2.5)	1.6 (0.4–4.2)	2 (1.3)	1.1 (0.1–4.0)
Hypertensive crisis	2 (1.3)	0.8 (0.1–2.9)	3 (1.9)	2.2 (0.6–5.7)
Abdominal pain	2 (1.3)	0.8 (0.1–2.9)	1 (0.6)	1.7 (0.3–4.9)
Upper respiratory tract infection	0	0	4 (2.5)	2.8 (0.9–6.5)
Arteriovenous fistula thrombosis	1 (0.6)	0.4 (0.0–2.3)	4 (2.5)	2.2 (0.6–5.7)
Hyperkalemia	1 (0.6)	0.8 (0.1–2.9)	2 (1.3)	1.7 (0.3–4.9)

CI confidence interval; EAER exposure-adjusted event rate; SAE serious adverse event