TABLE 2.
Duration of CompEx, SevEx and AWE events with benralizumab and placebo in patients aged ≥16 years with a baseline blood eosinophil count ≥300 cells·µL−1 in the SIROCCO and CALIMA studies (pooled data)
Benralizumab | Placebo | |||||
CompEx | SevEx | AWE | CompEx | SevEx | AWE | |
Patients,# n | 410 | 313 | 234 | 523 | 425 | 331 |
Events per patient, mean | 2.3 | 1.8 | 2.3 | 3.2 | 2.4 | 3.0 |
Percentage of days with an event ¶ | ||||||
Mean±sd | 6.9±11.4 | 5.3±6.9 | 5.3±11.4 | 8.4±10.8 | 6.5±7.9 | 5.6±9.7 |
Median (range) | 2.8 (0.5–90.1) | 2.9 (0.8–61.5) | 1.4 (0.5–90.1) | 4.7 (0.5–75.1) | 4.1 (0.3–64.4) | 1.7 (0.5–74.9) |
Duration of events, days | ||||||
Mean±sd | 24.6±42.2 | 17.0±19.8 | 20.5±45.9 | 33.1±45.4 | 22.2±26.2 | 25.9±46.6 |
Median (range) | 10.5 (2.0–317.0) | 10.0 (1.0–206.0) | 5.0 (2.0–315.0) | 17.0 (2.0–278.0) | 15.0 (1.0–217.0) | 6.0 (2.0–272.0) |
CompEx: composite end-point for exacerbations; SevEx: severe exacerbations; AWE: acute worsening events. #: summary statistics are presented for those patients who experienced an event (i.e. those without an event are excluded); ¶: calculated as a percentage of the total days at risk (of an event) in the study, for each patient.