TABLE 4

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

Tiotropium 5 µgTiotropium 2.5 µgPlacebo
Age 1–5 years [23]
 Subjects313634
 Any AEs18 (58.1)20 (55.6)25 (73.5)
 Drug-related AEs2 (6.5)02 (5.9)
 AEs leading to discontinuation000
 Serious AEs003 (8.8)
 AEs reported in ≥5% and ≥10 patients#
  Asthma exacerbation/worsening2 (6.5)5 (13.9)10 (29.4)
Age 6–11 years [21, 22]
 Subjects265271265
 Any AEs138 (52.1)145 (53.5)155 (58.5)
 Drug-related AEs1 (0.4)04 (1.5)
 AEs leading to discontinuation2 (0.8)02 (0.8)
 Serious AEs5 (1.9)5 (1.8)8 (3.0)
 AEs reported in ≥5% and ≥10 patients#
  Asthma exacerbation/worsening70 (26.4)69 (25.5)87 (32.8)
  Decreased peak expiratory flow rate44 (16.6)46 (17.0)47 (17.7)
  Nasopharyngitis/rhinopharyngitis18 (6.8)21 (7.7)24 (9.1)
Age 12–17 years [18, 19]
 Subjects264252273
 Any AEs127 (48.1)121 (48.0)130 (47.6)
 Drug-related AEs4 (1.5)1 (0.4)2 (0.7)
 AEs leading to discontinuation003 (1.1)
 Serious AEs5 (1.9)3 (1.2)2 (0.7)
 AEs reported in ≥5% and ≥10 patients#
  Asthma exacerbation/worsening38 (14.4)41 (16.3)46 (16.8)
  Nasopharyngitis/rhinopharyngitis24 (9.1)18 (7.1)20 (7.3)
  Decreased peak expiratory flow rate11 (4.2)18 (7.1)21 (7.7)
  Viral respiratory tract infection11 (4.2)11 (4.4)14 (5.1)

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.