Skip to main content

Table 2 Adverse events over the whole INBUILD trial in subgroups by BMI at baseline

From: Weight loss and outcomes in subjects with progressive pulmonary fibrosis: data from the INBUILD trial

 

BMI < 25 kg/m2

BMI ≥ 25 to < 30 kg/m2

BMI ≥ 30 kg/m2

Nintedanib (n = 90)

Placebo (n = 98)

Nintedanib (n = 130)

Placebo (n = 112)

Nintedanib (n = 111)

Placebo (n = 121)

 

n (%)

Rate per 100

patient-years

n (%)

Rate per 100

patient-years

n (%)

Rate per 100

patient-years

n (%)

Rate per 100

patient-years

n (%)

Rate per 100

patient-years

n (%)

Rate per 100

patient-years

Any adverse event(s)

89 (98.9)

1048.3

95 (96.9)

435.8

127 (97.7)

589.3

104 (92.9)

288.4

109 (98.2)

716.1

109 (90.1)

281.7

Most frequent adverse eventsa

 Diarrhea

71 (78.9)

199.2

25 (25.5)

23.3

92 (70.8)

130.9

29 (25.9)

23.3

77 (69.4)

112.8

31 (25.6)

22.5

 Nausea

27 (30.0)

30.7

9 (9.2)

6.9

39 (30.0)

30.5

11 (9.8)

7.4

33 (29.7)

30.5

13 (10.7)

8.2

 Vomiting

19 (21.1)

18.2

3 (3.1)

2.2

21 (16.2)

14.9

5 (4.5)

3.3

24 (21.6)

19.4

8 (6.6)

4.8

 Decreased appetite

21 (23.3)

22.1

9 (9.2)

6.8

18 (13.8)

11.9

7 (6.3)

4.6

15 (13.5)

10.8

7 (5.8)

4.2

 Nasopharyngitis

19 (21.1)

19.9

23 (23.5)

20.2

21 (16.2)

14.3

14 (12.5)

9.5

14 (12.6)

9.7

11 (9.1)

6.9

 Dyspnea

14 (15.6)

13.0

11 (11.2)

8.4

19 (14.6)

12.6

27 (24.1)

19.4

19 (17.1)

13.4

19 (15.7)

12.0

 Bronchitis

12 (13.3)

11.2

19 (19.4)

15.5

21 (16.2)

14.4

20 (17.9)

14.3

15 (13.5)

10.7

25 (20.7)

16.4

 Weight decrease

19 (21.1)

18.8

7 (7.1)

5.2

18 (13.8)

12.0

8 (7.1)

5.2

12 (10.8)

8.5

3 (2.5)

1.7

 ALT increased

14 (15.6)

13.9

2 (2.0)

1.5

18 (13.8)

11.9

5 (4.5)

3.2

17 (15.3)

12.0

6 (5.0)

3.6

 Cough

8 (8.9)

7.2

9 (9.2)

6.9

15 (11.5)

9.8

12 (10.7)

8.1

17 (15.3)

12.1

30 (24.8)

20.8

 Progression of ILDb

9 (10.0)

8.1

27 (27.6)

22.3

12 (9.2)

7.3

17 (15.2)

11.1

7 (6.3)

4.6

12 (9.9)

7.2

 AST increased

15 (16.7)

15.2

2 (2.0)

1.5

13 (10.0)

8.5

4 (3.6)

2.6

15 (13.5)

10.3

7 (5.8)

4.2

Adverse event(s) leading to treatment discontinuation

27 (30.0)

24.0

18 (18.4)

13.2

27 (20.8)

16.6

15 (13.4)

9.5

19 (17.1)

12.4

15 (12.4)

8.8

Adverse event(s) leading to dose reduction

44 (48.9)

63.8

4 (4.1)

3.0

46 (35.4)

40.0

2 (1.8)

1.3

34 (30.6)

28.2

9 (7.4)

5.4

Serious adverse event(s)c

42 (46.7)

46.4

57 (58.2)

56.0

59 (45.4)

44.2

57 (50.9)

45.4

46 (41.4)

36.7

50 (41.3)

35.0

Fatal adverse event(s)

4 (4.4)

3.4

12 (12.2)

8.7

10 (7.7)

6.0

16 (14.3)

10.1

7 (6.3)

4.5

8 (6.6)

4.6

  1. Based on adverse events reported between the first trial drug intake and 28 days after the last trial drug intake
  2. ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, MedDRA Medical Dictionary for Regulatory Activities
  3. aAdverse events were coded based on preferred terms in the MedDRA version 22.0. Adverse events with an incidence rate of >10 events per 100 patient-years in either treatment group in the overall population are shown
  4. bCorresponded to the MedDRA preferred term “interstitial lung disease”
  5. cEvent that resulted in death, was life-threatening, resulted in hospitalization or prolonged hospitalization, resulted in persistent or clinically significant disability or incapacity, was a congenital anomaly or birth defect, or was deemed serious for any other reason