Table 4.
n (%) | Placebo (n = 33) | ASP5094 (n = 33) |
---|---|---|
TEAE | 13 (39.4%) | 20 (60.6%) |
Mild | 9 (27.3%) | 13 (39.4%) |
Moderate | 4 (12.1%) | 6 (18.2%) |
Severe | 0 | 1 (3.0%) |
Drug-related TEAE | 2 (6.1%) | 5 (15.2%) |
Serious TEAE | 1 (3.0%) | 2 (6.1%) |
Drug-related serious TEAE | 0 | 1 (3.0%) |
TEAE leading to permanent discontinuation | 0 | 2 (6.1%) |
Drug-related TEAE leading to discontinuation | 0 | 1 (3.0%) |
Serious TEAE leading to permanent discontinuation | 0 | 0 |
Death | 0 | 0 |
TEAEs experienced by > 1 patient overall | ||
Rheumatoid arthritis | 4 (12.1%) | 6 (18.2%) |
Viral upper respiratory tract infection | 3 (9.1%) | 4 (12.1%) |
Constipation | 1 (3.0%) | 3 (9.1%) |
Influenza | 1 (3.0%) | 2 (6.1%) |
Chest discomfort | 2 (6.1%) | 1 (3.0%) |
Cystitis | 1 (3.0%) | 1 (3.0%) |
Pneumonia | 1 (3.0%) | 1 (3.0%) |
TEAE treatment-emergent adverse event