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Table 2 Summary of safety data (pooled safety population)

From: Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies

 GFF MDI 18/9.6 μg (n = 1588)GP MDI 18 μg (n = 1364)FF MDI 9.6 μg (n = 1370)Placebo MDI (n = 678)All patients (n = 5000)
TEAEs, n (%) [number of events]
  ≥ 1 TEAE923 (58.1) [2317]750 (55.0) [1946]762 (55.6) [1866]386 (56.9) [921]2821 (56.4) [7050]
  Mild396 (24.9)317 (23.2)348 (25.4)174 (25.7)1235 (24.7)
  Moderate404 (25.4)326 (23.9)308 (22.5)162 (23.9)1200 (24.0)
  Severe123 (7.7)107 (7.8)106 (7.7)50 (7.4)386 (7.7)
 Drug-relateda TEAEs172 (10.8) [276]150 (11.0) [256]144 (10.5) [228]69 (10.2) [115]535 (10.7) [875]
 Serious TEAEs133 (8.4) [171]107 (7.8) [155]106 (7.7) [129]50 (7.4) [65]396 (7.9) [520]
 Drug-relateda serious TEAEs10 (0.6) [11]15 (1.1) [21]8 (0.6) [9]3 (0.4) [3]36 (0.7) [44]
 TEAEs leading to early discontinuation91 (5.7) [125]80 (5.9) [133]71 (5.2) [120]43 (6.3) [56]285 (5.7) [434]
Deaths (all causes)
 Treatment period5 (0.3)1 (0.1)2 (0.1)2 (0.3)10 (0.2)
 Treatment period + 14 days6 (0.4)2 (0.1)2 (0.1)2 (0.3)12 (0.2)
TEAEs occurring in ≥2% of patients in any treatment arm, preferred term, n (%)
 Upper respiratory tract infection70 (4.4)67 (4.9)59 (4.3)42 (6.2)238 (4.8)
 Viral upper respiratory tract infection75 (4.7)61 (4.5)71 (5.2)26 (3.8)233 (4.7)
 Cough54 (3.4)37 (2.7)32 (2.3)14 (2.1)137 (2.7)
 COPDb40 (2.5)42 (3.1)30 (2.2)20 (2.9)132 (2.6)
 Dyspnea35 (2.2)32 (2.3)35 (2.6)26 (3.8)128 (2.6)
 Nasopharyngitis45 (2.8)25 (1.8)29 (2.1)19 (2.8)118 (2.4)
 Sinusitis28 (1.8)27 (2.0)33 (2.4)16 (2.4)104 (2.1)
 Headache30 (1.9)31 (2.3)35 (2.6)7 (1.0)103 (2.1)
 Back pain36 (2.3)29 (2.1)25 (1.8)11 (1.6)101 (2.0)
 Bronchitis24 (1.5)35 (2.6)18 (1.3)17 (2.5)94 (1.9)
 Hypertension28 (1.8)20 (1.5)21 (1.5)24 (3.5)93 (1.9)
 Pneumonia28 (1.8)24 (1.8)18 (1.3)17 (2.5)87 (1.7)
 Urinary tract infection33 (2.1)21 (1.5)14 (1.0)12 (1.8)80 (1.6)
  1. aPossibly, probably, or definitely related to study drug, as per investigator’s judgment prior to unblinding. bWorsening of COPD defined as a COPD exacerbation since the patient’s last visit. COPD exacerbations were only recorded as an AE if they were considered to be a serious TEAE
  2. COPD chronic obstructive pulmonary disease, FF formoterol fumarate, GFF glycopyrrolate/formoterol fumarate, GP glycopyrrolate, MDI metered dose inhaler, TEAE treatment-emergent adverse event