Table 4.
Safety events in age subgroup from weeks 0 to 12
| Placebo | Baricitinib 4 mg | |||||
| Total (N=716) |
<65 years (N=603) |
≥65 years (N=113) | Total (N=714) |
<65 years (N=578) |
≥65 years (N=136) | |
| ≥1 Adverse events | 633 | 524 (86.9) | 109 (96.5) | 636 | 503 (87.0) | 133 (97.8) |
| SAEa | 22 | 15 (2.5) | 7 (6.2) | 16 | 10 (1.7) | 6 (4.4) |
| Cardiac disorders | 3 | 2 (0.3) | 1 (0.9) | 1 | 1 (0.2) | 0 |
| Serious infections | 8 | 6 (1.0) | 2 (1.8) | 6 | 3 (0.5) | 3 (2.2) |
| Zoster | 0 | 0 | 0 | 2 | 0 | 2 (1.5) |
| Tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignancies | 1 | 0 | 1 (0.9) | 1 | 1 (0.2) | 0 |
| Discontinuation from study | 21 | 15 (2.5) | 6 (5.3) | 20 | 13 (2.2) | 7 (5.1) |
| Death | 2 | 2 (0.3) | 0 | 0 | 0 | 0 |
Data presented as n (%).
N, number of patients in the specified treatment subgroup; n, number of patients in the specified category
a
SAE, serious adverse event, reported on the basis of conventional International Conference on Harmonisation definitions.