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Table 4 Adverse events (reported irrespective of causality) in subgroups of patients by weight loss over 52 weeksa

From: Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis

 

Weight loss ≤ 5%

Weight loss > 5%

Nintedanib (n = 397)

Placebo (n = 338)

Nintedanib (n = 241)

Placebo (n = 85)

Adverse event(s)

376 (94.7)

297 (87.9)

233 (96.7)

82 (96.5)

Most frequent adverse event(s)b

 Diarrhoea

216 (54.4)

56 (16.6)

177 (73.4)

22 (25.9)

 Progression of IPFc

30 (7.6)

41 (12.1)

34 (14.1)

20 (23.5)

 Dyspnoea

24 (6.0)

37 (10.9)

25 (10.4)

11 (12.9)

 Nausea

90 (22.7)

20 (5.9)

66 (27.4)

8 (9.4)

 Pneumonia

21 (5.3)

14 (4.1)

12 (5.0)

12 (14.1)

 Nasopharyngitis

46 (11.6)

59 (17.5)

41 (17.0)

9 (10.6)

 Decreased appetite

31 (7.8)

14 (4.1)

37 (15.4)

10 (11.8)

 Cough

57 (14.4)

45 (13.3)

28 (11.6)

12 (14.1)

 Bronchitis

43 (10.8)

33 (9.8)

24 (10.0)

12 (14.1)

 Vomiting

39 (9.8)

9 (2.7)

35 (14.5)

2 (2.4)

 Upper respiratory tract infection

40 (10.1)

33 (9.8)

18 (7.5)

9 (10.6)

 Abdominal pain

31 (7.8)

8 (2.4)

25 (10.4)

2 (2.4)

 Weight decreased

14 (3.5)

3 (0.9)

48 (19.9)

12 (14.1)

 Arthralgia

8 (2.0)

12 (3.6)

6 (2.5)

9 (10.6)

Adverse event(s) leading to treatment discontinuation

72 (18.1)

38 (11.2)

51 (21.2)

17 (20.0)

Severe adverse event(s)d

94 (23.7)

72 (21.3)

80 (33.2)

27 (31.8)

Serious adverse event(s)e

97 (24.4)

86 (25.4)

97 (40.2)

41 (48.2)

Fatal adverse event(s)

20 (5.0)

25 (7.4)

17 (7.1)

6 (7.1)

  1. Data are n (%) of patients with ≥1 such adverse event reported over 52 weeks plus a 4-week post-treatment follow-up period. aBased on the annual rate of decline in weight. bAdverse events by MedDRA preferred term reported in ≥10% of patients in ≥1 of the subgroups shown. cCorresponds to MedDRA term ‘IPF’, which included disease worsening and acute exacerbations. dEvent that was incapacitating or that caused an inability to work or to perform usual activities. eEvent that resulted in death, was immediately life-threatening, resulted in persistent or clinically significant disability or incapacity, required or prolonged hospitalisation, was related to a congenital anomaly or birth defect, or was deemed serious for any other reason