TABLE 3

Overview of patients reporting adverse events (AEs) in the pooled population: treated set (treatment plus 30 days following treatment)

Tiotropium 5 µgTiotropium 2.5 µgPlacebo
Subjects560559572
Any AEs283 (50.5)286 (51.2)310 (54.2)
Drug-related AEs7 (1.3)1 (0.2)8 (1.4)
AEs leading to discontinuation2 (0.4)05 (0.9)
Serious AEs10 (1.8)8 (1.4)13 (2.3)
AEs reported in ≥5% and ≥10 patients#
 Asthma exacerbation/worsening110 (19.6)115 (20.6)143 (25.0)
 Decreased peak expiratory flow rate55 (9.8)64 (11.4)68 (11.9)
 Nasopharyngitis/rhinopharyngitis44 (7.9)46 (8.2)49 (8.6)
 Viral respiratory tract infection27 (4.8)24 (4.3)30 (5.2)

Data are presented as n or n (%). Percentages are calculated using total number of patients per treatment as the denominator. #: in at least one treatment group.