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Table 2 Treatment interruptions in the INBUILD trial

From: Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial

 

Nintedanib (n = 332)

Placebo (n = 331)

Patients with ≥ 1 treatment interruption

128 (38.6)

41 (12.4)

Number of treatment interruptions per patient

 0

204 (61.4)

290 (87.6)

 1

81 (24.4)

32 (9.7)

 2

30 (9.0)

7 (2.1)

 > 2

17 (5.1)

2 (0.6)

Total number of treatment interruptions

197

52

Time to first treatment interruption (days)

 ≤ 31

21 (6.3)

8 (2.4)

 > 31 to ≤ 91

33 (9.9)

9 (2.7)

 > 91 to ≤ 182

27 (8.1)

7 (2.1)

 > 182

47 (14.2)

17 (5.1)

Total duration of treatment interruptions (days), mean (SD)

25.7 (20.1)

24.1 (22.0)

Most frequent reasons for treatment interruption considered related to trial drug, n (%) of interruptionsa

 Diarrhea

73 (37.1)

5 (9.6)

 ALT increased

14 (7.1)

1 (1.9)

 Hepatic function abnormal

10 (5.1)

1 (1.9)

 AST increased

7 (3.6)

0

 Vomiting

7 (3.6)

1 (1.9)

 Nausea

6 (3.0)

1 (1.9)

  1. Data are n (%) of patients unless otherwise stated. Adverse events shown were reported between first trial drug intake and 28 days after last trial drug intake. Median exposure to trial drug was 17.4 months in both groups
  2. ALT alanine aminotransferase, AST aspartate aminotransferase
  3. aAdverse events were coded based on preferred terms in the Medical Dictionary for Regulatory Activities version 22.0. Adverse events that led to > 2 treatment interruptions in either treatment group are shown. Percentages are based on the total number of treatment interruptions