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Table 5 Number of events needed to explore the effect of therapy in patients with COPD

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

 

Events

Power (%)

Year

GOLD II

GOLD III

GOLD IV

Overall

80

1

226

845

436

429

 

2

331

1367

638

605

 

3

375

1467

1244

695

 

4

546

2538

1499

1033

85

1

259

967

499

491

 

2

379

1564

730

692

 

3

429

1678

1423

795

 

4

625

2903

1714

1181

90

1

303

1131

584

575

 

2

443

1830

854

810

 

3

503

1964

1666

930

 

4

731

3397

2006

1383

  1. The calculations were made with a power of 80 %, 85 %, and 90 % at p < 0.05
  2. GOLD Global Initiative for Chronic Obstructive Lung Disease