Table 6—

Exposure-adjusted incidence rates (IR; per 100 patient-yrs) of serious and fatal exacerbations of chronic obstructive pulmonary disease (COPD) in the tiotropium and placebo group according to onset of event

OnsetTiotropium#PlaceboRisk ratio (95% CI)tiotropium/placebo
nExposureIRnExposureIR
Serious COPD exacerbation
 0–ET455088.97248914.70.60 (0.41–0.87)
 0–ED364108.84637112.40.71 (0.46–1.10)
 ED–ET9989.22611722.10.42 (0.19–0.89)
 0–ED30384827.96144213.80.57 (0.38–0.86)
 ED30–ET72626.9114723.51.15 (0.45–2.96)
Fatal COPD exacerbation
 0–ET0523055101.0N/A
 0–ED0416013800.3N/A
 ED–ET0107041303.1N/A
 0–ED300491034550.7N/A
 ED30–ET03202553.7N/A
  • n: number of events; CI: confidence interval; 0–ET: randomisation to end of trial (entire trial period); 0–ED: randomisation to end of drug (time on treatment); ED–ET: end of drug to end of trial (time off treatment); 0–ED30: randomisation to end of drug (time on treatment) plus 30 days; ED30–ET: from 31 days after end of drug to end of trial; N/A: no patients in the tiotropium group had a fatal COPD exacerbation. #: n = 914; : 915.