TABLE 4

Incidences of adverse events (intent-to-treat population)

UMECGLYCO
Patients n516518
Adverse event category
 Any on-treatment adverse event193 (37)188 (36)
 Any on-treatment drug-related adverse event#17 (3)18 (3)
 Any on-treatment non-fatal SAE15 (3)13 (3)
 Any on-treatment non-fatal drug-related SAE#1 (<1)0
 Any on-treatment fatal SAE2 (<1)2 (<1)
On-treatment AE reported by ≥3% of subjects in either group by preferred term
 Headache42 (8)51 (10)
 Nasopharyngitis42 (8)39 (8)
Non-fatal SAE reported by ≥2 patients by preferred term
 COPD7 (1)5 (<1)
 Pneumonia2 (<1)0
 Atrial fibrillation1 (<1)1 (<1)
AE of special interest by preferred term
 Cardiovascular events12 (2)11 (2)
 Pneumonia4 (<1)4 (<1)
 LRTI excluding pneumonia5 (<1)6 (1)
  • Data are presented as n (%), unless otherwise stated. #: drug-related adverse events (AEs) or severe adverse events (SAEs) were defined by the study investigator; : chronic obstructive pulmonary disease (COPD) was listed as an AE by the participating investigator and was likely due to a worsening of the underlying condition. GLYCO: glycopyrronium; UMEC: umeclidinium; LRTI: lower respiratory tract infection.