Table 2 Distribution of ADRs according to SOC classification
Tot ADRs N (% out of 834) | Serious ADRs N (% out of corresponding SOC) | |
|---|---|---|
SOC | ||
Gastrointestinal disorders | 228 (27.34) | 68 (29.82) |
General disorders and administration site conditions | 179 (21.46) | 41 (23.56) |
Skin and subcutaneous tissue disorders | 135 (16.19) | 17 (12.59) |
Nervous system disorders | 108 (12.95) | 45 (41.67) |
Metabolism and nutrition disorders | 30 (3.60) | 11 (36.67) |
Respiratory, thoracic and mediastinal disorders | 27 (3.24) | 8 (29.63) |
Musculoskeletal and connective tissue disorders | 27 (3.24) | 11(40.74) |
Psychiatric disorders | 18 (2.16) | 7 (38.89) |
Eye disorders | 13 (1.56) | 5 (38.46) |
Cardiac disorders | 12 (1.44) | 5 (41.67) |
Ear and labyrinth disorders | 10 (1.20) | 1 (10) |
Investigations | 8 (0.96) | 3 (37.50) |
Infections and infestations | 8 (0.96) | 1 (12.50) |
Vascular disorders | 7 (0.84) | 2 (28.57) |
Injury, poisoning and procedural complications | 7 (0.84) | 4 (57.14) |
Blood and lymphatic system disorders | 5 (0.60) | 3 (60.00) |
Reproductive system and breast disorders | 4 (0.48) | 0 (0.00) |
Renal and urinary disorders | 4 (0.48) | 3 (75.00) |
Immune system disorders | 3 (0.36) | 3 (100.00) |
Surgical and medical procedures | 1(0.12) | 1 (100.00) |