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Table 4 IR and RR of the occurrence of CERO in tiotropium and placebo groups for GOLD stage II, and combined GOLD stages III and IV over a 4-year period

From: Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial

GOLD stage II
  Tiotropium (n = 1554) Control (n = 1602) Tiotropium/control
Year N (%) Patient-year IRa N (%) Patient-year IRa RR p-value
        (95 % CI)  
1 114 (7) 1312.9 8.7 158 (10) 1255.7 12.6 0.69 0.0025
        (0.54–0.88)  
2 187 (12) 2543.0 7.4 242 (15) 2408.5 10.0 0.73 0.0013
        (0.60–0.89)  
3 249 (16) 3709.7 6.7 312 (20) 3483.4 9.0 0.75 0.0007
        (0.63–0.89)  
4 304 (20) 4818.7 6.3 361 (23) 4501.6 8.0 0.79 0.0021
        (0.68–0.92)  
GOLD stage III/IV (combined)
  Tiotropium (n = 1554) Control (n = 1602) Tiotropium/control
Year N (%) Patient-year IRa N (%) Patient-year IRa RR p-value
        (95 % CI)  
1 315 (20) 1354.3 23.3 385 (24) 1340.5 28.7 0.81 0.0055
        (0.70–0.94)  
2 465 (30) 2520.0 18.5 541 (34) 2476.8 21.8 0.84 0.0077
        (0.75–0.96)  
3 579 (37) 3547.6 16.3 659 (41) 3474.6 19.0 0.86 0.0084
        (0.77–0.96)  
4 675 (43) 4475.1 15.1 743 (46) 4378.0 17.0 0.89 0.0266
        (0.80–0.99)  
  1. N = number of events
  2. CI confidence interval, GOLD Global Initiative for Chronic Obstructive Lung Disease, IR incidence rate, RR risk ratio
  3. aPer 100 patient-years