Table 5—

Exposure-adjusted incidence rates (IR; per 100 patient-yrs) of total (any), cardiac and lower respiratory fatal events in the tiotropium and placebo group according to onset of event

OnsetTiotropium#PlaceboRisk ratio (95% CI)tiotropium/placebo
nExposureIRnExposureIR
Any fatal event
 0–ET315166.0315066.10.98 (0.60, 1.61)
 0–ED84161.973801.81.04 (0.38, 2.88)
 ED–ET2310023.02412619.01.21 (0.68, 2.14)
 0–ED30224904.5194544.21.07 (0.58, 1.98)
 ED30–ET92634125223.11.47 (0.62, 3.49)
Cardiac fatal event
 0–ET65231.2105092.00.58 (0.21, 1.61)
 0–ED34160.723800.51.37 (0.23, 8.20)
 ED–ET31072.881296.20.45 (0.12, 1.70)
 0–ED3034910.664551.30.46 (0.12, 1.85)
 ED30–ET3329.44547.41.26 (0.28, 5.65)
Lower respiratory fatal event
 0–ET65221.2105092.00.59 (0.21, 1.61)
 0–ED34160.733800.80.91 (0.18, 4.52)
 ED–ET31062.871295.40.52 (0.14, 2.02)
 0–ED3034910.674551.50.40 (0.10, 1.54)
 ED30–ET3319.73545.51.75 (0.36, 8.71)
  • n: number of events; CI: confidence interval; 0–ET: entire trial period; 0–ED: time on treatment; ED–ET: time off treatment; 0–ED30: time on treatment plus 30 days; ED30–ET: time off treatment starting 31 days after study drug. #: n = 914; : n = 915.