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. 2017 Jan 6;18:8. doi: 10.1186/s12931-016-0491-8

Table 4.

Summary of adverse events (safety population)

GFF MDI GP MDI 36 μg (N = 41) Open-label tiotropium 18 μg (N = 58) FF MDI Placebo MDI (N = 52) Open-label FFa DPI 12 μg (N = 55)
72/9.6 μg (N = 41) 36/9.6 μg (N = 43) 9.6 μg (N = 64) 7.2 μg (N = 64)
Patients with at least one AE, n (%) 17 (41.5) 18 (41.9) 11 (26.8) 22 (37.9) 24 (37.5) 16 (25.0) 9 (17.3) 17 (30.9)
Patients with AE related to study treatment, n (%) 13 (31.7) 12 (27.9) 7 (17.1) 7 (12.1) 7 (10.9) 4 (6.3) 2 (3.8) 7 (12.7)
Patients with SAE, n (%) 0 1 (2.3) 0 2 (3.4) 1 (1.6) 2 (3.1) 0 0
Patients with SAE related to study treatment, n (%) 0 0 0 0 0 0 0 0
Patients with AE leading to early withdrawal, n (%) 1 (2.4) 0 1 (2.4) 1 (1.7) 4 (6.3) 3 (4.7) 1 (1.9) 0
Patients with SAE leading to early withdrawal, n (%) 0 0 0 0 0 2 (3.1) 0 0
TEAEs reported in ≥2 patients in any treatment group
 Dry mouth 8 (19.5) 3 (7.0) 5 (12.2) 4 (6.9) 3 (4.7) 2 (3.1) 1 (1.9) 2 (3.6)
 Headache 3 (7.3) 4 (9.3) 1 (2.4) 1 (1.7) 1 (1.6) 0 1 (1.9) 2 (3.6)
 Tremor 1 (2.4) 5 (11.6) 0 0 0 0 0 0
 Cough 0 2 (4.7) 0 1 (1.7) 0 0 0 0
 Dysphonia 1 (2.4) 2 (4.7) 0 0 0 0 0 0

% = 100 × n/N: n = no. of patients in the preferred term category for treatment group

aForadil® Aerolizer®

AE adverse event, DPI dry powder inhaler, FF formoterol fumarate, GFF glycopyrrolate/formoterol fumarate, GP glycopyrrolate, MDI metered dose inhaler, SAE serious adverse event, TEAE treatment-emergent adverse event