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