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Table 3 Comparison of serious adverse events between the advanced and non-advanced idiopathic pulmonary fibrosis groups

From: Efficacy and safety of nintedanib in advanced idiopathic pulmonary fibrosis

Characteristic

Total

Advanced

Non-advanced

P-value

Number of patients

108

51

57

 

Serious adverse events

59 (54.6)

32 (62.7)

27 (47.4)

0.109

 Pneumonia

30 (27.8)

16 (31.4)

14 (24.6)

0.430

 Acute exacerbation

9 (8.3)

5 (9.8)

4 (7.0)

0.732

 Pneumothorax

6 (5.6)

5 (9.8)

1 (1.8)

0.098

 Lung cancer

4 (3.7)

1 (2.0)

3 (5.3)

0.620

 Pulmonary thromboembolism

3 (2.8)

1 (2.0)

2 (3.5)

1.000

 Cardiac disordersa

3 (2.8)

1 (2.0)

2 (3.5)

1.000

 Cerebral vascular disease

1 (0.9)

1 (2.0)

0 (0.0)

0.472

 Death

18 (16.7)

11 (21.6)

7 (12.3)

0.196

  Pneumonia

10 (9.3)

7 (13.7)

3 (5.3)

0.186

  Acute exacerbation

2 (1.9)

0 (0.0)

2 (1.9)

0.497

  Severe liver injuryb

1 (0.9)

0 (0.0)

1 (1.8)

1.000

  Cancer progression

1 (0.9)

1 (2.0)

0 (0.0)

0.472

  Myocardial infarction

1 (0.9)

0 (0.0)

1 (1.8)

1.000

  Unknown

3 (2.8)

1 (2.0)

2 (3.5)

1.000

  1. Data are presented as numbers (%), unless otherwise indicated
  2. aIncludes acute myocardial infarction, stable angina and atrial fibrillation
  3. bDefined as an aspartate transaminase or alanine transaminase level of > 5× the upper normal limit or presence of hepatic failure