Skip to main content

Table 3 IRs and RRs of the individual events included in the composite COPD endpoint CERO in placebo and tiotropium groups 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

  Tiotropium (n = 2986) Control (n = 3006) Tiotropium/control
Event by year N (%) Patient-year IRa N (%) Patient-year IRa RR-year p-value
        (95 % CI)  
Fatal event
 1 162 (5) 2675.7 6.1 182 (6) 2576.8 7.1 0.86 0.1538
        (0.69-1.06)  
 2 238 (8) 5067.4 4.7 261 (9) 4797.4 5.4 0.86 0.1010
        (0.72-1.03)  
 3 307 (10) 7222.9 4.3 339 (11) 6741.5 5.0 0.85 0.0328
        (0.72-0.99)  
 4 376 (13) 9169.5 4.1 408 (14) 8459.5 4.8 0.85 0.0232
        (0.74-0.98)  
Serious adverse event: Respiratory failure
 1 31 (1) 2726.9 1.1 51 (2) 2626.3 1.9 0.59 0.0187
        (0.37-0.91)  
 2 48 (2) 5152.6 0.9 67 (2) 4866.5 1.4 0.68 0.0389
        (0.47-0.98)  
 3 68 (2) 7324.4 0.9 88 (3) 6809.8 1.3 0.72 0.0406
        (0.52-0.99)  
 4 83 (3) 9267.4 0.9 112 (4) 8513.8 1.3 0.68 0.0079
        (0.51-0.90)  
Serious adverse event: Hospitalization due to exacerbation
 1 272 (9) 2630.9 10.3 326 (11) 2513.9 13.0 0.80 0.0058
        (0.68-0.94)  
 2 440 (15) 4825.7 9.1 507 (17) 4515.4 11.2 0.81 0.0014
        (0.71-0.92)  
 3 573 (19) 6701.1 8.6 641 (21) 6161.6 10.4 0.82 0.0006
        (0.73-0.92)  
 4 681 (23) 8308.8 8.2 735 (25) 7555.3 9.7 0.84 0.0013
        (0.76-0.94)  
Trial discontinuation due to worsening of COPD
 1 92 (3) 2741.3 3.4 178 (6) 2644.4 6.7 0.50 <0.0001
        (0.39-0.64)  
 2 146 (5) 5179.9 2.8 250 (8) 4906.4 5.1 0.55 <0.0001
        (0.45-0.68)  
 3 202 (7) 7366.6 2.7 317 (11) 6871.0 4.6 0.59 <0.0001
        (0.50-0.71)  
 4 237 (8) 9326.7 2.5 367 (12) 8598.9 4.3 0.60 <0.0001
        (0.51-0.70)  
  1. N = number of events
  2. CI confidence interval, COPD chronic obstructive pulmonary disease, IR incidence rate, RR risk ratio
  3. aPer 100 patient-years