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. 2019 Jan 18;14:249–260. doi: 10.2147/COPD.S185485

Table 2.

Treatment-emergent AEs and SAEs during the study period (safety set)

Characteristics* Tiotropium N=268 SFC N=101 IND/GLY N=373

Patient with ≥1 AE (s) 72 (26.9) 34 (33.7) 107 (28.7)
 COPD 8 (3.0) 5 (5.0) 13 (3.5)
 Upper respiratory tract infection 7 (2.6) 3 (3.0) 11 (2.9)
 Cough 9 (3.4) 1 (1.0) 10 (2.7)
 Bronchitis 7 (2.6) 2 (2.0) 9 (2.4)
 Dyspnea 5 (1.9) 2 (2.0) 7 (1.9)
 Pneumonia 2 (0.7) 5 (5.0) 7 (1.9)
Patient with ≥1 SAE(s) 4 (1.5) 8 (7.9) 12 (3.2)
 Pneumonia 1 (0.4) 3 (3.0) 4 (1.1)
 COPD 0 (0) 2 (2.0) 2 (0.5)
 SAEs requiring hospitalization or prolonged hospitalization 2 (0.7) 5 (5.0) 7 (1.9)
Discontinuations due to AEs or SAEs 15 (5.6) 9 (8.9) 24 (6.4)
 Discontinuation due to SAEs 2 (0.7) 1 (1.0) 3 (0.8)
 Discontinuation due to non-SAEs 13 (4.9) 8 (7.9) 21 (5.6)

Notes:

*

Covers all AEs or SAEs experienced by ≥2% of overall study population (safety set). Data are presented as n (%).

Abbreviations: AE, adverse events; IND/GLY, indacaterol/glycopyrronium; SAE, serious AE.