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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