Table 4—

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

OnsetTiotropium#PlaceboRisk ratio (95% CI)tiotropium/placebo
nExposureIRnExposureIR
Any SAE
 0–ET17446437.517045637.31.01 (0.82–1.24)
 0–ED14638737.812935536.31.04 (0.82–1.32)
 ED–ET287736.34110140.60.89 (0.55–1.45)
 0–ED3016244936.115642837.30.97 (0.78–1.21)
 ED30–ET121579.5143836.82.16 (1.00–4.67)
Cardiac SAE
 0–ET385127.45449510.90.68 (0.45–1.03)
 0–ED304117.3333748.80.83 (0.51–1.36)
 ED–ET81017.92112117.40.45 (0.20–1.03)
 0–ED30334836.84844610.80.64 (0.41–0.99)
 ED30–ET52917.364912.21.42 (0.43–4.65)
Lower respiratory SAE
 0–ET8049616.110348021.40.75 (0.56–1.01)
 0-ED64415.86936818.70.85 (0.60–1.19)
 ED–ET169217.43411230.30.58 (0.32–1.04)
 0–ED307247415.29043720.60.74 (0.54–1.01)
 ED30–ET82235.9134429.61.21 (0.50–2.93)
  • 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.