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Table 3 Summary of adverse events

From: Glycopyrrolate/formoterol fumarate metered dose inhaler for maintenance-naïve patients with chronic obstructive pulmonary disease: a post-hoc analysis of the randomized PINNACLE trials

 NMTMT
TreatmentGFF
(n = 638)
FF
(n = 548)
GP
(n = 516)
Placebo
(n = 241)
GFF
(n = 947)
FF
(n = 812)
GP
(n = 846)
Placebo
(n = 435)
TEAEs, n (%)
 Patients with ≥1 TEAE362 (56.7)304 (55.5)280 (54.3)133 (55.2)560 (59.1)457 (56.3)469 (55.4)252 (57.9)
 Patients with serious TEAEs43 (6.7)33 (6.0)35 (6.8)18 (7.5)90 (9.5)73 (9.0)72 (8.5)32 (7.4)
 Deaths (all-cause) during treatment period1 (0.2)1 (0.2)0 (0)1 (0.4)4 (0.4)1 (0.1)1 (0.1)1 (0.2)
TRAEs, n (%)
 Patients with TEAEs related to study treatment75 (11.8)58 (10.6)51 (9.9)19 (7.9)97 (10.2)86 (10.6)99 (11.7)50 (11.5)
 Patients with serious TEAEs related to study treatment7 (1.1)1 (0.2)6 (1.2)1 (0.4)3 (0.3)7 (0.9)9 (1.1)2 (0.5)
Common TEAEs, n (%)
 Upper respiratory tract infection28 (4.4)20 (3.6)26 (5.0)13 (5.4)42 (4.4)39 (4.8)41 (4.8)29 (6.7)
 Viral upper respiratory tract infection31 (4.9)28 (5.1)20 (3.9)10 (4.1)44 (4.6)43 (5.3)41 (4.8)16 (3.7)
 Dyspnea11 (1.7)8 (1.5)7 (1.4)7 (2.9)24 (2.5)27 (3.3)25 (3.0)19 (4.4)
 Nasopharyngitis14 (2.2)14 (2.6)9 (1.7)10 (4.1)31 (3.3)15 (1.8)16 (1.9)9 (2.1)
 Back pain17 (2.7)12 (2.2)10 (1.9)9 (3.7)19 (2.0)13 (1.6)19 (2.2)2 (0.5)
 Cough23 (3.6)11 (2.0)14 (2.7)6 (2.5)31 (3.3)21 (2.6)23 (2.7)8 (1.8)
 COPD14 (2.2)11 (2.0)16 (3.1)5 (2.1)26 (2.7)19 (2.3)26 (3.1)15 (3.4)
 Bronchitis9 (1.4)5 (0.9)9 (1.7)2 (0.8)15 (1.6)13 (1.6)26 (3.1)15 (3.4)
 Hypertension14 (2.2)5 (0.9)6 (1.2)8 (3.3)14 (1.5)16 (2.0)14 (1.7)16 (3.7)
 Headache15 (2.4)17 (3.1)11 (2.1)3 (1.2)15 (1.6)18 (2.2)20 (2.4)4 (0.9)
  1. Common TEAEs defined as those occurring in ≥ 3% of patients in any treatment arm. COPD Chronic obstructive pulmonary disease, FF Formoterol fumarate, GFF Glycopyrrolate and formoterol fumarate, GP Glycopyrrolate, MT Maintenance-treated at screening, NMT Not maintenance-treated at screening, TEAE Treatment-emergent adverse event, TRAE Treatment-related adverse event