Table 3 Incidence rate of events reported by system organ classification (grouped by MedDRA® coding) in the total cohort (N = 10,925)
MedDRA® System organ classification | Number of events, (n) | Incidence rate per 1,000 (n/N) |
|---|---|---|
Blood and lymphatic system disorders | 15 | 1. 4 |
Cardiac disorders | 5 | 0. 5 |
Congenital, familial and genetic disorders | 3 | 0. 3 |
Ear and labyrinth disorders | 2 | 0. 2 |
Eye disorders | 8 | 0. 7 |
Gastrointestinal disorders | 150 | 13. 7 |
General disorders and administrative site conditions | 83 | 7. 6 |
Immune system disorders | 1 | 1. 0 |
Infections and infestations | 354 | 32. 4 |
Injury, poisoning and procedural complications | 5 | 0. 5 |
Metabolism and nutrition disorders | 14 | 1. 3 |
Musculoskeletal and connective tissue disorders | 12 | 1. 1 |
Nervous system disorders | 50 | 4. 6 |
Pregnancy, puerperium and perinal conditions | 1 | 0. 1 |
Psychiatric disorders | 4 | 0. 4 |
Renal and urinary disorders | 2 | 0. 2 |
Reproductive system and breast disorders | 2 | 0. 2 |
Respiratory, thoracic and mediastinal disorders | 59 | 5. 4 |
Skin and subcutaneous tissue disorders | 26 | 2. 4 |
Other | 1 | 0. 1 |