Table 7.
Summary of infection/infestation adverse events in the integrated analysis of phase III GALATHEA and TERRANOVA trials during the on-treatment period (safety analysis set)
| GALATHEA/TERRANOVA trials | ||
|---|---|---|
| Benralizumab (n = 2792) | Placebo (n = 1118) | |
| Any infection/infestation AE | 1425 (51.0) | 547 (48.9) |
| Any infection/infestation AE for ≥ 3% of patients | ||
|
Viral URTI URTI Bronchitis Lower respiratory tract infection Pneumonia Urinary tract infection |
336 (12.0) 329 (11.8) 324 (11.6) 135 (4.8) 122 (4.4) 118 (4.2) |
129 (11.5) 128 (11.4) 139 (12.4) 46 (4.1) 58 (5.2) 32 (2.9) |
| Infection/infestation AEs of note based on literature search | ||
|
Herpes zoster Viral infection Parasitic gastroenteritis Helminth infections |
25 (0.9) 16 (0.6) NR NR |
12 (1.1) 8 (0.7) NR NR |
| Any serious AE (including death) | 165 (5.9) | 75 (6.7) |
| Any AE leading to treatment discontinuation | 18 (0.6) | 8 (0.7) |
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, NR not reported, URTI upper respiratory tract infection