TABLE 4

Incidence of treatment-emergent adverse events by preferred MedDRA term affecting >5% of patients (safety analysis set)

IND/GLY/MF a.m.IND/GLY/MF p.m.PlaceboTotal
Patients35353637
Number of patients with ≥1 adverse event18 (51.4)23 (65.7)18 (50.0)32 (86.5)
Headache5 (14.3)3 (8.6)7 (19.4)10 (27.0)
Nasopharyngitis2 (5.7)2 (5.7)5 (13.9)8 (21.6)
Oropharyngeal pain3 (8.6)4 (11.4)2 (5.6)7 (18.9)
Cough1 (2.9)2 (5.7)1 (2.8)4 (10.8)
Dysphonia2 (5.7)3 (8.6)1 (2.8)4 (10.8)
Asthma1 (2.9)1 (2.9)1 (2.8)3 (8.1)
Throat clearing1 (2.9)1 (2.9)0 (0.0)2 (5.4)

Data are presented as n or n (%). MedDRA: Medical Dictionary for Regulatory Activities; IND: indacaterol acetate; GLY: glycopyrronium bromide; MF: mometasone furoate.