Table 3.
Incidence Rate of Events Reported by System Organ Class (Grouped by MedDRA Coding) in the Two Cohorts
| MedDRA System Organ Class | Total (N=3170) | Active Cohort (n=2679) | Passive Cohort (n=491) | |||
|---|---|---|---|---|---|---|
| na | IRb | na | IRb | na | IRb | |
| General disorders | 703 | 221.8 | 568 | 212.0 | 135 | 274.9 |
| Gastrointestinal disorders | 551 | 173.8 | 415 | 154.9 | 136 | 277.0 |
| Respiratory, thoracic and mediastinal disorders | 348 | 109.8 | 290 | 108.2 | 58 | 118.1 |
| Ear and labyrinth disorders | 252 | 79.5 | 208 | 77.6 | 44 | 89.6 |
| Psychiatric disorders | 207 | 65.3 | 134 | 50.0 | 73 | 148.7 |
| Skin and subcutaneous tissue disorders | 66 | 20.8 | 59 | 22.0 | 7 | 14.3 |
| Musculoskeletal and connective tissue disorders | 61 | 19.2 | 49 | 18.3 | 12 | 24.4 |
| Blood and lymphatic system disorders | 32 | 10.1 | 26 | 9.7 | 6 | 12.2 |
| Nervous system disorders | 30 | 9.5 | 19 | 7.1 | 11 | 22.4 |
| Eye disorders | 21 | 6.6 | 15 | 5.6 | 6 | 6.1 |
| Renal and urinary disorders | 9 | 2.8 | 8 | 3.0 | 1 | 2.0 |
| Pregnancy, puerperium and perineal conditions | 2 | 0.6 | 2 | 0.7 | 0 | 0 |
Notes: aIndicates the number of events; a patient could have one or more events at a time. bIndicates the incidence rate per 1000 (n/N).