Table 5.
Baricitinib | |||||
---|---|---|---|---|---|
Placebo (N = 8) | 2 mg (N = 8) | 4 mg (N = 9) | 10 mg (N = 8) | Overall (N = 33) | |
All causalities | |||||
Number of subjects (%) with ≥1 AE | 4 (50.0) | 1 (12.5) | 2 (22.2) | 4 (50.0) | 11 (33.3) |
Total number of TEAEs (all severities were “mild”), n | 10 | 2 | 3 | 6 | 21 |
Drug related (number of TEAEs [number of subjects with TEAEs]) | |||||
ECG abnormal | 6 (2) | 0 | 0 | 0 | 6 (2) |
ALT increased | 1 (1) | 0 | 1 (1) | 2 (2) | 4 (4) |
AST increased | 1 (1) | 0 | 1 (1) | 1 (1) | 3 (3) |
Bilirubin increased | 0 | 0 | 0 | 1 (1) | 1 (1) |
ANC decreased | 0 | 0 | 1 (1) | 0 | 1 (1) |
Hypotension | 1 (1) | 0 | 0 | 0 | 1 (1) |
Orthostatic hypotension, n | 0 | 0 | 0 | 1 (1) | 1 (1) |
Overall | 9 (4) | 0 (0) | 3 (2) | 5 (4) | 17 (10) |
AEs, adverse events; ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; ECG, electrocardiogram; TEAEs, treatment‐emergent adverse events.