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Table 4 Total number of events of special interest 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 = 2022
BiKeR
N = 1697
Infections: 1523 (75.3%) 1509 (89%)
 Serious/targeted infections (Epstein–Barr virus, cytomegalovirus, papilloma virus, herpes zoster primary and reactivation, and opportunistic infections) 674 (33.3%) 171 (10.1%)
 Tuberculosis 27 (1,3%) 0
 Other infections 822 (40.6%) 1338 (78.8%)
Infusion/injection related reactions: 218 (10.8%) 24 (1.4%)
 Infusion related reaction 144 (7.1%) 11 (0.6%)
 Injection related reaction 74 (3.7%) 13 (0.8%)
Blood cell–related events of special interest (ESI): 188 (9.3%) 90 (5.3%)
 Pancytopenia 6 (0.3%) 65 (3.8%)
 Neutropenia 107 (5.3%) 14 (0.8%)
 Macrophage activation syndrome 75 (3.7%) 11 (0.6%)
 Aplastic anemia 0 0
Autoimmune ESI: 50 (2.5%) 50 (2.9%)
 Inflammatory bowel disease (IBD) 21 (1.1%) 23 (1.3)
 Other autoimmune diseases excluding IBD, uveitis, and demyelinisation disorders 18 (0.9%) 24 (1.4%)
 Lupus erythematosus systemic/lupus-like syndrome 4 (0.2%) 1 (0.1%)
 Optic neuritis 4 (0.2%) 0
 Multiple sclerosis 2 (0.1%) 0
 Demyelination 1 (0.05%) 2 (0.2%)
Malignancies: 16 (0.8%) 13 (0.8%)
 Leukemias 3 (0.1%) 2 (0.2%)
 Lymphomas 2 (0.1%) 5 (0.3%)
 Hematopoietic neoplasms (excluding leukemias and lymphomas) 1 (0.05%) 2 (0.2%)
 Neoplasm (other) 10 (0.5%) 4 (0.2%)
Others ESI: 27 (1.3%) 11 (0.6%)
 Gastrointestinal (GI) ulcer/GI bleed/GI perforation 17 (0.8%) 4 (0.2%)
 Pregnancy 9 (0.4%) 7 (0.4%)
 Congestive heart failure 1 (0.05%) 0
  1. Data are absolute numbers and frequencies (percentage)