Table 2.
Incidence of adverse events by frequency (reported by more than one subject)
Treatment group | ||||
---|---|---|---|---|
Placebo (n = 5) | Mavrilimumab* (n = 27) | |||
Adverse event | No of AEs | No (%) of subjects | No of AEs | No (%) of subjects |
Total | 13 | 4 (80) | 69 | 20 (74) |
Nasopharyngitis | 3 | 2 (40) | 11 | 10 (37) |
Headache | 2 | 2 (40) | 7 | 5 (19) |
Diarrhoea | 1 | 1 (20) | 5 | 5 (19) |
Back pain | 1 | 1 (20) | 4 | 4 (15) |
Peripheral oedema | 0 | 0 | 3 | 3 (11) |
Nausea | 1 | 1 (20) | 2 | 2 (7) |
Bronchitis | 0 | 0 | 2 | 2 (7) |
Dizziness | 0 | 0 | 2 | 2 (7) |
Hypertension | 0 | 0 | 2 | 2 (7) |
Pharyngolaryngeal pain | 0 | 0 | 2 | 2 (7) |
Vomiting | 1 | 1 (20) | 1 | 1 (4) |
All doses. AEs were classified according to the terminology of the Medical Dictionary for Regulatory Activities (version 11).
AE, adverse event.