Table 3.
Summary of TEAEs/SAEs during treatment with placebo and baricitinib at weeks 0–24 and weeks 0–52
| Safety data | Weeks 0–24 | Weeks 0–52 | |
|---|---|---|---|
| Placebo (N = 115) n (%) |
BARI 4 mg (N = 116) n (%) | BARI 4 mg (N = 116) n (%) | |
| SAEs* | 4 (3.5) | 2 (1.7) | 4 (3.4) |
| TEAEs | 71 (61.7) | 88 (75.9) | 110 (86.2) |
| Discontinuation from study due to AE | 3 (2.6) | 2 (1.7) | 3 (2.6) |
| Infections | 35 (30.4) | 50 (43.1) | 67 (57.8) |
| Herpes zoster | 1 (0.9) | 2 (1.7) | 3 (2.6) |
| Venous thromboembolism | 0 | 0 | 0 |
| Tuberculosis | 0 | 0 | 0 |
| Serious infections | 1 (0.9) | 1 (0.9) | 2 (1.7) |
AE adverse events, BARI baricitinib, N number of Chinese patients in the safety population, n number of patients in the specified category, SAE serious adverse event, TEAE treatment-emergent adverse events
*SAEs reported using International Conference on Harmonization definitions