TABLE 6

Overview of patients reporting adverse events (AEs) in subgroups by sex: treated set (treatment plus 30 days following treatment)

Tiotropium 5 µgTiotropium 2.5 µgPlacebo
Males
 Subjects365373366
 Any AEs195 (53.4)190 (50.9)201 (54.9)
 Drug-related AEs5 (1.4)05 (1.4)
 AEs leading to discontinuation2 (0.5)03 (0.8)
 Serious AEs7 (1.9)6 (1.6)4 (1.1)
 AEs reported in ≥5% and ≥10 patients#
  Asthma exacerbation/worsening75 (20.5)73 (19.6)94 (25.7)
  Decreased peak expiratory flow rate38 (10.4)49 (13.1)44 (12.0)
  Nasopharyngitis/rhinopharyngitis29 (7.9)34 (9.1)34 (9.3)
  Viral respiratory tract infection16 (4.4)14 (3.8)22 (6.0)
  Respiratory tract infection14 (3.8)11 (2.9)20 (5.5)
Females
 Subjects195186206
 Any AEs88 (45.1)96 (51.6)109 (52.9)
 Drug-related AEs2 (1.0)1 (0.5)3 (1.5)
 AEs leading to discontinuation002 (1.0)
 Serious AEs3 (1.5)2 (1.1)9 (4.4)
 AEs reported in ≥5% and ≥10 patients#
  Asthma exacerbation/worsening35 (17.9)42 (22.6)49 (23.8)
  Decreased peak expiratory flow rate17 (8.7)15 (8.1)24 (11.7)
  Nasopharyngitis/rhinopharyngitis15 (7.7)12 (6.5)15 (7.3)
  Viral respiratory tract infection11 (5.6)10 (5.4)8 (3.9)

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.