Table 3.
Most common serious adverse events in the full analysis set (those with exposure-adjusted event rates per 100 person-years of >1) by age subgroup
| Infants aged <1 year (n = 13) | Children aged 1–5 years (n = 83) | Children aged 6–11 years (n = 90) | Children aged ≥12 years (n = 133) | |||||
|---|---|---|---|---|---|---|---|---|
| Patients reporting, n (%) | EAER/100 person-years (95 % CI) | Patients reporting, n (%) | EAER/100 person-years (95 % CI) | Patients reporting, n (%) | EAER/100 person-years (95 % CI) | Patients reporting, n (%) | EAER/100 person-years (95 % CI) | |
| Any SAE | 7 (53.8) | 149.0 (94.4–223.5) | 51 (61.4) | 152.8 (130.3–178.1) | 39 (43.3) | 69.0 (55.4–85.0) | 65 (48.9) | 90.4 (76.9–105.6) |
| Peritonitis | 1 (7.7) | 13.0 (1.6–46.8) | 13 (15.7) | 16.8 (9.9–26.5) | 10 (11.1) | 11.0 (6.0–18.4) | 8 (6.0) | 5.7 (2.7–10.5) |
| Hypertension | 1 (7.7) | 6.5 (0.16–36.1) | 6 (7.2) | 10.3 (5.1–18.3) | 4 (4.4) | 3.1 (0.9–8.0) | 2 (1.5) | 4.0 (1.6–8.2) |
| Gastroenteritis | 2 (15.4) | 13.0 (1.6–46.8) | 8 (9.6) | 8.4 (3.8–15.9) | 2 (2.2) | 1.6 (0.2–5.7) | 7 (5.3) | 5.1 (2.3–9.7) |
| Convulsions | 1 (7.7) | 25.9 (7.1–66.3) | 4 (5.8) | 4.7 (1.5–10.9) | 4 (4.4) | 4.7 (1.7–10.2) | 1 (0.8) | 0.6 (0.0–3.2) |
| Diarrhea | 1 (7.7) | 6.5 (0.16–36.1) | 1 (1.2) | 1.9 (0.2–6.7) | 2 (2.2) | 1.6 (0.2–5.7) | 4 (3.0) | 3.4 (1.3–7.4) |
| Vomiting | 0 | 0 | 4 (5.8) | 3.7 (1.0–9.5) | 1 (1.1) | 0.8 (0.0–4.4) | 3 (2.3) | 1.7 (0.4–5.0) |
| Urinary tract infection | 0 | 0 | 3 (3.6) | 2.8 (0.6–8.2) | 0 | 0 | 4 (3.0) | 2.8 (0.9–6.6) |
| Renal failure chronic | 0 | 0 | 5 (6.0) | 4.7 (1.5–10.9) | 0 | 0 | 2 (1.5) | 1.1 (0.1–4.1) |
| Sepsis | 0 | 0 | 3 (3.6) | 2.8 (0.6–8.2) | 1 (1.1) | 0.8 (0.0–4.4) | 3 (2.3) | 1.7 (0.4–5.0) |
| Pneumonia | 0 | 0 | 1 (1.2) | 0.9 (0.0–5.2) | 2 (2.2) | 2.4 (0.5–6.9) | 3 (2.3) | 1.7 (0.4–5.0) |
| Pyelonephritis | 0 | 0 | 0 | 0 | 1 (1.1) | 0.8 (0.0–4.4) | 5 (3.8) | 3.4 (1.3–7.4) |
| Pyrexia | 1 (7.7) | 6.5 (0.16–36.1) | 3 (3.6) | 5.6 (2.1–12.2) | 0 | 0 | 0 | 0 |
| Medical device complication | 0 | 0 | 2 (2.4) | 3.7 (1.0–9.5) | 1 (1.1) | 0.8 (0.0–4.4) | 1 (0.8) | 0.6 (0.0–3.2) |
| Bronchitis | 0 | 0 | 3 (3.6) | 2.8 (0.6–8.2) | 3 (3.3) | 2.4 (0.5–6.9) | 0 | 0 |
| Catheter site infection | 2 (15.4) | 13.0 (1.6–46.8) | 1 (1.2) | 0.9 (0.0–5.2) | 1 (1.1) | 0.8 (0.0–4.4) | 2 (1.5) | 1.1 (0.1–4.1) |
| Device-related infection | 1 (7.7) | 6.5 (0.16–36.1) | 2 (2.4) | 1.9 (0.2–6.7) | 1 (1.1) | 0.8 (0.0–4.4) | 2 (1.5) | 1.1 (0.1–4.1) |
| Dehydration | 0 | 0 | 5 (6.0) | 4.7 (1.5–10.9) | 0 | 0 | 1 (0.8) | 0.6 (0.0–3.2) |
| Hypertensive crisis | 0 | 0 | 0 | 0 | 0 | 0 | 5 (3.8) | 3.4 (1.3–7.4) |
| Abdominal pain | 0 | 0 | 1 (1.2) | 2.8 (0.6–8.2) | 2 (2.2) | 1.6 (0.2–5.7) | 0 | 0 |
| Upper respiratory tract infection | 0 | 0 | 3 (3.6) | 3.7 (1.0–9.5) | 0 | 0 | 1 (0.8) | 0.6 (0.0–3.2) |
| Arteriovenous fistula thrombosis | 0 | 0 | 0 | 0 | 1 (1.1) | 0.8 (0.0–4.4) | 4 (3.0) | 2.3 (0.6–5.8) |
| Hyperkalemia | 0 | 0 | 2 (2.4) | 3.7 (1.0–9.5) | 1 (1.1) | 0.8 (0.0–4.4) | 0 | 0 |
CI confidence interval; EAER exposure-adjusted event rate; SAE serious adverse event