Table 3– Adverse events, serious adverse events (SAEs), deaths and discontinuations over the 26-week treatment period
PlaceboQVA149 110/50 μgIndacaterol 150 μgGlycopyrronium 50 μgTiotropium 18 μg
Subjects n232474476473480
Patients with any adverse event134 (57.8)261 (55.1)291 (61.1)290 (61.3)275 (57.3)
 COPD91 (39.2)137 (28.9)153 (32.1)150 (31.7)138 (28.8)
 Nasopharyngitis23 (9.9)31 (6.5)35 (7.4)46 (9.7)40 (8.3)
 Cough8 (3.4)26 (5.5)38 (8.0)18 (3.8)21 (4.4)
 Upper respiratory tract infection13 (5.6)20 (4.2)32 (6.7)20 (4.2)24 (5.0)
 Oropharyngeal pain7 (3.0)17 (3.6)7 (1.5)10 (2.1)10 (2.1)
 Viral upper respiratory tract infection7 (3.0)15 (3.2)11 (2.3)13 (2.7)12 (2.5)
 Bacterial upper respiratory tract infection13 (5.6)10 (2.1)13 (2.7)15 (3.2)22 (4.6)
 Lower respiratory tract infection5 (2.2)9 (1.9)15 (3.2)7 (1.5)12 (2.5)
 Back pain5 (2.2)8 (1.7)11 (2.3)17 (3.6)8 (1.7)
Serious adverse events13 (5.6)22 (4.6)26 (5.5)29 (6.1)19 (4.0)
Adjudicated CCV events
 Atrial fibrillation/flutter, new onset02 (0.4)3 (0.6)2 (0.4)1 (0.2)
Serious CCV events1 (0.4)06 (1.3)7 (1.5)4 (0.8)
 MACE002 (0.4)3 (0.6)3 (0.6)
  Nonfatal myocardial infarction0001 (0.2)0
  Nonfatal stroke001 (0.2)02 (0.4)
  Heart failure requiring hospitalisation001 (0.2)1 (0.2)0
  Coronary revascularisation#0001 (0.2)2 (0.4)
 Non-MACE1 (0.4)04 (0.8)6 (1.3)3 (0.6)
Deaths01 (0.2)2 (0.4)1 (0.2)3 (0.6)
Discontinuations
 Due to an adverse event10 (4.3)6 (1.3)24 (5.0)14 (3.0)10 (2.1)
 Due to a SAE3 (1.3)3 (0.6)11 (2.3)6 (1.3)5 (1.0)
  • Data are presented as n (%), unless otherwise stated. The most common events are listed, affecting ≥3% of patients in any of the active treatment groups. COPD: chronic obstructive pulmonary disease; CCV: cardio- and cerebrovascular; MACE: major adverse cardiac event. #: coronary artery bypass graft or percutaneous coronary intervention; : adjudicated events.