Table 4.
Adverse events | Mavrilimumab* (N=42) |
Placebo (N=28) |
Patients with ≥1 adverse event | 33 (78.6%) | 25 (89.3%) |
Serious adverse event | 2 (4.8%) | 3 (10.7%) |
Serious adverse event related to study drug | 0 | 0 |
Adverse event resulting in death | 0 | 0 |
Adverse event leading to study drug discontinuation | 1 (2.4%) | 1 (3.6%) |
Adverse events by maximum severity† | ||
Mild | 18 (42.9%) | 13 (46.4%) |
Moderate | 14 (33.3%) | 11 (39.3%) |
Severe | 1 (2.4%) | 1 (3.6%) |
Most common adverse events‡ | ||
Headache | 6 (14.3%) | 7 (25.0%) |
Nasopharyngitis | 5 (11.9%) | 3 (10.7%) |
Neck pain | 4 (9.5%) | 2 (7.1%) |
Arthralgia | 2 (4.8%) | 4 (14.3%) |
Hypertension | 1 (2.4%) | 4 (14.3%) |
Back pain | 3 (7.1%) | 3 (10.7%) |
Muscle spasms | 3 (7.1%) | 3 (10.7%) |
Upper respiratory tract infection | 3 (7.1%) | 2 (7.1%) |
Constipation | 3 (7.1%) | 0 |
Diarrhoea | 0 | 3 (10.7%) |
Fall | 2 (4.8%) | 5 (17.9%) |
Data are n (%).
*150 mg subcutaneously every 2 weeks.
†Each patient is represented only with maximum severity.
‡Reported in >2 patients in either treatment group.