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Table 3 Total number of adverse events by MedDRA system organ class ordered by decreasing frequencies

From: Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries

  Pharmachild
N = 5173
BiKeR
N = 5013
Infections and infestations 1523 (29.4%) 1509 (30.1%)
Gastrointestinal disorders 595 (11.5%) 984 (19.6%)
Injury, poisoning and procedural complications 325 (6.3%) 152 (3.1%)
Blood and lymphatic system disorders 291 (5.6%) 99 (2%)
Investigations 285 (5.5%) 377 (7.5%)
Eye disorders 270 (5.2%) 309 (6.2%)
Skin and subcutaneous tissue disorders 256 (4.9%) 217 (4.3%)
General disorders and administration site conditions 245 (4.7%) 410 (8.2%)
Hepatobiliary disorders 233 (4.5%) 24 (0.5%)
Surgical and medical procedures 209 (4.1%) 98 (2%)
Nervous system disorders 151 (2.9%) 227 (4.5%)
Musculoskeletal and connective tissue disorders 147 (2.8%) 138 (2.7%)
Respiratory, thoracic, and mediastinal disorders 112 (2.2%) 50 (1%)
Psychiatric disorders 105 (2.1%) 157 (3.1%)
Endocrine disorders 104 (2.0%) 6 (0.1%)
Metabolism and nutrition disorders 77 (1.5%) 34 (0.7%)
Renal and urinary disorders 66 (1.3%) 21 (0.4%)
Immune system disorders 33 (0.6%) 77 (1.5%)
Vascular disorders 30 (0.6%) 46 (0.9%)
Reproductive system and breast disorders 26 (0.5%) 13 (0.3%)
Congenital, familial, and genetic disorders 22 (0.4%) 9 (0.2%)
Cardiac disorders 19 (0.4%) 13 (0.3%)
Neoplasms benign, malignant, and unspecified (including cysts and polyps) 16 (0.3%) 29 (0.6%)
Ear and labyrinth disorders 13 (0.3%) 7 (0.1%)
Social circumstances 11 (0.2%) 0
Pregnancy, puerperium and perinatal conditions 9 (0.2%) 7 (0.1%)
  1. Data are absolute numbers and frequencies (percentage)
  2. Abbreviation: BiKeR Biologics in Pediatric Rheumatology Registry, MedDRA Medical Dictionary for Regulatory Activities