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Table 3 On-treatment AEs occurring in ≥3% of patients in any treatment group (ITT population)

From: A phase IIb, randomised, parallel-group study: the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids

 Placebo (N =143)
n (%)
UMEC 31.25 mcg (N =139)
n (%)
UMEC 62.5 mcg (N =139)
n (%)
Any AE65 (45)73 (53)57 (41)
 Nasopharyngitis17 (12)14 (10)13 (9)
 Upper respiratory tract infection3 (2)8 (6)6 (4)
 Respiratory tract infection viral5 (3)7 (5)4 (3)
 Oropharyngeal pain2 (1)6 (4)4 (3)
 Dysphonia2 (1)6 (4)0
 Headache11 (8)9 (6)12 (9)
 Toothache4 (3)1 (<1)5 (4)
 Back pain5 (3)3 (2)1 (<1)
 Arthralgia1 (<1)5 (4)2 (1)
 Hypertension5 (3)4 (3)1 (<1)
Drug-related AEs4 (3)6 (4)3 (2)
AEs leading to permanent discontinuation of study treatment1 (<1)1 (<1)1 (<1)
AEs leading to withdrawal from the study1 (<1)00
Any SAE5 (3)4 (3)3 (2)
Drug-related SAEs000
Fatal SAEs000
Fatal drug-related SAEs000
  1. AEs listed by preferred term
  2. AE adverse event, ITT intent-to-treat, SAE serious AE, UMEC umeclidinium