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 |