Table 2.
Adverse events in the phase III SIROCCO or CALIMA trials preceding BORA by preferred term frequency ≥ 3% during the on-treatment period
| Adverse event | Benralizumab (n = 1663) | Placebo (n = 847) |
|---|---|---|
| Nasopharyngitis | 266 (16.0) | 141 (16.6) |
| Asthma | 225 (13.5) | 151 (17.8) |
| URTI | 144 (8.7) | 79 (9.3) |
| Headache | 135 (8.1) | 53 (6.3) |
| Bronchitis | 132 (7.9) | 84 (9.9) |
| Sinusitis | 85 (5.1) | 69 (8.1) |
| Influenza | 74 (4.4) | 49 (5.8) |
| Pharyngitis | 67 (4.0) | 22 (2.6) |
| Allergic rhinitis | 60 (3.6) | 32 (3.8) |
| Pyrexia | 57 (3.4) | 14 (1.7) |
| Rhinitis | 56 (3.4) | 32 (3.8) |
| Hypertension | 52 (3.1) | 35 (4.1) |
| Arthralgia | 51 (3.1) | 22 (2.6) |
Data are presented as n (%). Group names are treatment received in the SIROCCO or CALIMA trials preceding BORA (safety analysis set, n = 1663 for benralizumab and n = 847 for placebo). The safety analysis set consists of all patients who received at least one dose of benralizumab or placebo in SIROCCO or CALIMA. The on-treatment period was defined as the day of the first dose of study treatment to the scheduled end-of-treatment visit. Adverse events were defined according to the Medical Dictionary for Regulatory Activities (MedDRA®) Version 18.1 for SIROCCO/CALIMA and Version 20.0 for BORA
URTI upper respiratory tract infection