5. Incidence of safety outcomes from RCTs.
| Outcome | Total # studies with data | # Events*: biologic group | # People: biologic group |
Incidence in biologic group | # Events*: control group | # people: control group | Incidence in control group | Total # events |
Total # people studied | Total duration of studies (mths (yrs)) |
| SAE | 125 | 2926 | 26032 | 11.24% | 1747 | 13,614 | 12.83% | 4673 | 39,646 | 2613 (217.8) |
| S Infections | 117 | 731 | 25,486 | 2.87% | 325 | 13,741 | 2.37% | 1056 | 39,227 | 2923 (243.6) |
| Total AE | 115 | 20,686 | 24,208 | 85.45% | 11,115 | 13,241 | 83.94% | 31,801 | 37,449 | 2462 (205.2) |
| With d/t AE | 128 | 1577 | 26,553 | 5.94% | 683 | 14,172 | 4.82% | 2260 | 40,725 | 2909.2 (242.4) |
| TB | 71 | 32 | 20,765 | 0.154% | 3 | 9915 | 0.030% | 35 | 30,671 | 646.1 (53.8) |
| Lymphoma | 52 | 14 | 14,254 | 0.098% | 6 | 7006 | 0.086% | 20 | 21,260 | 518.3 (43.2) |
| CHF | 24 | 27 | 5768 | 0.468% | 17 | 3079 | 0.552% | 44 | 8847 | 255.6 (21.3) |
All drug doses included
# Events* = number of events or people with events