Table 2

Adverse event profile

TiotropiumPlacebo
Subjects n550371
Adverse events n (%)495 (90.0)338 (91.1)
Adverse events considered drug related104 (18.9)34 (9.2)*
Dry mouth n (%)88 (16.0)10 (2.7)*
Deaths7 (1.3)7 (1.9)
Serious adverse events n (%)99 (18.0)78 (21.0)
Adverse events leading to discontinuation n (%)53 (9.6)51 (13.7)
  • *: p<0.05