Table 4 Incidence of adverse events recorded in patients with juvenile idiopathic arthritis
By age | p Value | Total | ||
|---|---|---|---|---|
< 16 years | ≥16 years | |||
Total adverse events | 457.6 (414.1–505.7) | 346.9 (325.4–369.8) | < 0.001 | 373.2 (353.6–393.8) |
Serious adverse events | 35.7 (24.9–51.0) | 43.2 (36.1–51.8) | 0.347 | 41.4 (35.2–48.7) |
Fatal adverse events | 1.2 (0.2–8.4) | – | 0.999 | 0.3 (0.0–2.0) |
By system/organ class | ||||
Infections and infestations | 253.2 (221.4–289.6) | 136.0 (122.8–150.6) | < 0.001 | 163.8 (151–177.6) |
Gastrointestinal disorders | 30.9 (21.0–45.4) | 18.1 (13.7–24.0) | 0.028 | 21.1 (16.9–26.5) |
Skin and subcutaneous tissue disorders | 17.8 (10.7–29.6) | 21.1 (16.2–27.3) | 0.797 | 20.3 (16.1–25.6) |
General disorders and administration site conditions | 21.4 (13.5–34.0) | 20.0 (15.3–26.0) | 0.566 | 20.3 (16.1–25.6) |
Eye disorders | 23.8 (15.3–36.8) | 13.3 (9.6–18.4) | 0.037 | 15.8 (12.1–20.5) |
Musculoskeletal and connective tissue disorders | 11.9 (6.4–22.1) | 11.8 (8.4–16.7) | 0.988 | 11.8 (8.7–16) |
Surgical and medical procedures | 3.6 (1.2–11.1) | 13.7 (9.9–18.9) | 0.025 | 11.3 (8.3–15.4) |
Nervous system disorders | 10.7 (5.6–20.6) | 11.5 (8.1–16.3) | 0.857 | 11.3 (8.3–15.4) |
Blood and lymphatic system disorders | 10.7 (5.6–20.6) | 8.9 (5.9–13.2) | 0.631 | 9.3 (6.6–13.1) |
Renal and urinary disorders | 3.6 (1.2–11.1) | 11.1 (7.7–15.9) | 0.061 | 9.3 (6.6–13.1) |
Reproductive system and breast disorders | 4.8 (1.8–12.7) | 9.6 (6.5–14.1) | 0.190 | 8.5 (5.9–12.1) |
Injury, poisoning, and procedural complications | 8.3 (4.0–17.5) | 8.1 (5.4–12.3) | 0.957 | 8.2 (5.7–11.8) |
Respiratory, thoracic, and mediastinal disorders | 11.9 (6.4–22.1) | 5.9 (3.6–9.6) | 0.083 | 7.3 (5–10.8) |
Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 3.6 (1.2–11.1) | 5.9 (3.6–9.6) | 0.422 | 5.4 (3.4–8.4) |
Hepatobiliary disorders | 2.4 (0.6–9.5) | 5.9 (3.6–9.6) | 0.225 | 5.1 (3.2–8.1) |
Metabolism and nutrition disorders | 1.2 (0.2–8.4) | 5.9 (3.6–9.6) | 0.120 | 4.8 (3–7.7) |
Pregnancy, puerperium, and perinatal conditions | 0.0 | 5.5 (3.3–9.2) | 0.997 | 4.2 (2.5–7) |
Vascular disorders | 1.2 (0.2–8.4) | 4.8 (2.8–8.3) | 0.178 | 3.9 (2.3–6.7) |
Psychiatric disorders | 5.9 (2.5–14.3) | 3.3 (1.7–6.4) | 0.298 | 3.9 (2.3–6.7) |
Ear and labyrinth disorders | 2.4 (0.6–9.5) | 3.0 (1.5–5.9) | 0.783 | 2.8 (1.5–5.2) |
Immune system disorders | 2.4 (0.6–9.5) | 2.6 (1.2–5.4) | 0.916 | 2.5 (1.3–4.9) |
Cardiac disorders | 3.6 (1.2–11.1) | 1.8 (0.8–4.4) | 0.368 | 2.3 (1.1–4.5) |
Endocrine disorders | 2.4 (0.6–9.5) | 1.5 (0.6–3.9) | 0.583 | 1.7 (0.8–3.8) |
Congenital, familial, and genetic disorders | 0.0 | 1.8 (0.8–4.4) | 0.403 | 1.4 (0.6–3.4) |