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. Author manuscript; available in PMC: 2014 Sep 23.
Published in final edited form as: J Allergy Clin Immunol. 2013 Jul 16;132(5):1086–1096.e5. doi: 10.1016/j.jaci.2013.05.020

Table II. Overall summary of adverse events (safety population).

Adverse Events Cohort 1 (single-dose IV)a N=13 Cohort 2 (multiple-dose SC)a N=14
Placebo
n=5		 Benralizumab 1 mg/kg
n=8		 Placebo
n=5		 Benralizumab 100 mg
n=4		 Benralizumab 200 mg
n=5		 Benralizumab total
n=9
Total number of AEs 17 27 20 15 10 25
Subjects reporting ≥1 AE, n (%) 5 (100) 5 (62.5) 5 (100) 4 (100) 2 (40.0) 6 (66.7)
AEs reported by ≥2 subjects, n (%) 5 (100) 5 (62.5) 5 (100) 4 (100) 2 (40.0) 6 (66.7)
 Nasopharyngitis 0 (0.0) 2 (25.0) 4 (80.0) 2 (50.0) 0 (0.0) 2 (22.2)
 Nausea 1 (20.0) 1 (12.5) 0 (0.0) 1 (25.0) 1 (20.0) 2 (22.2)
 Asthma 0 (0.0) 1 (12.5) 1 (20.0) 0 (0.0) 1 (20.0) 1 (11.1)
 Headache 0 (0.0) 2 (25.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Cough 1 (20.0) 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (11.1)
 Dyspnea 1 (20.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (20.0) 1 (11.1)
 Fatigue 1 (20.0) 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (11.1)
 Oropharyngeal pain 0 (0.0) 1 (12.5) 1 (20.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Rash 1 (20.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (20.0) 1 (11.1)
 Tremor 1 (20.0) 1 (12.5) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
 Anemia 0 (0.0) 0 (0.0) 2 (40.0) 0 (0.0) 0 (0.0) 0 (0.0)

Abbreviations: AE = adverse event; IV = intravenous; SC = subcutaneous;

a

Cohorts 1 and 2 were consecutive.