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Table 2 IR of the CERO endpoint in all patients enrolled in UPLIFT® study on years 1 to 4 of the study

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

Year

N (%)

Patient -year

IRa

N (%)

Patient-year

IRa

RR-year

p-value

       

(95 % CI)

 

1

436 (15)

2711.4

16.1

556 (19)

2637.5

21.1

0.76

<0.0001

       

(0.67–0.86)

 

2

664 (22)

5146.1

12.9

803 (27)

4959.0

16.2

0.80

<0.0001

       

(0.72–0.88)

 

3

843 (28)

7373.7

11.4

992 (33)

7059.6

14.1

0.81

<0.0001

       

(0.74–0.89)

 

4

995 (33)

9442.9

10.5

1128 (38)

9007.5

12.5

0.84

0.0001

       

(0.77–0.92)

 
  1. N = number of events
  2. CI confidence interval, IR incidence rate, RR risk ratio
  3. aPer 100 patient-years