Table 6.
Summary of adverse events in the integrated analysis of the phase III GALATHEA and TERRANOVA trials during the on-treatment period (safety analysis set)
| AEs | GALATHEA/TERRANOVA trials | |
|---|---|---|
| Benralizumab (n = 2792) | Placebo (n = 1118) | |
| Any AE | 2048 (73.4) | 809 (72.4) |
| Any AE for ≥ 3% of patients | ||
| COPD | 442 (15.8) | 181 (16.2) |
| Viral URTI | 336 (12.0) | 129 (11.5) |
| URTI | 329 (11.8) | 128 (11.4) |
| Bronchitis | 324 (11.6) | 139 (12.4) |
| Lower respiratory tract infection | 135 (4.8) | 46 (4.1) |
| Pneumonia | 122 (4.4) | 58 (5.2) |
| Urinary tract infection | 118 (4.2) | 32 (2.9) |
| Headache | 102 (3.7) | 42 (3.8) |
| Any serious AE (including death) | 736 (26.4) | 306 (27.4) |
| Any AE leading to treatment discontinuation | 132 (4.7) | 35 (3.1) |
| Any AE with outcome of death | 64 (2.3) | 24 (2.1) |
Data are presented as n (%). The safety analysis set included all patients from GALATHEA and TERRANOVA who received at least one dose of study treatment. The on-treatment period was defined as the day of the first dose of study treatment to the scheduled end-of-treatment visit. AEs were defined according to the Medical Dictionary for Regulatory Activities (MedDRA®) Version 20.0
AE adverse event, COPD chronic obstructive pulmonary disease, URTI upper respiratory tract infection