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

Table 1 Dose reductions in the INBUILD trial

	Nintedanib (n = 332)	Placebo (n = 331)
Patients with ≥ 1 dose reduction	131 (39.5)	20 (6.0)
Number of dose reductions
0	201 (60.5)	311 (94.0)
1	113 (34.0)	17 (5.1)
2	17 (5.1)	3 (0.9)
> 2	1 (0.3)	0
Total number of dose reductions	151	23
Time to first dose reduction (days)
≤ 31	18 (5.4)	3 (0.9)
> 31 to ≤ 91	30 (9.0)	10 (3.0)
> 91 to ≤ 182	36 (10.8)	3 (0.9)
> 182	47 (14.2)	4 (1.2)
Most frequent reasons for dose reduction considered related to trial drug, n (%) of dose reductions^a
Diarrhea	68 (45.0)	3 (13.0)
ALT increased	16 (10.6)	3 (13.0)
Hepatic function abnormal	11 (7.3)	1 (4.3)
Nausea	10 (6.6)	2 (8.7)
Weight decreased	7 (4.6)	0
AST increased	6 (4.0)	0
Vomiting	6 (4.0)	1 (4.3)
Decreased appetite	4 (2.6)	1 (4.3)
Blood alkaline phosphatase increased	3 (2.0)	0
Liver function test increased	3 (2.0)	0

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
ALT alanine aminotransferase, AST aspartate aminotransferase
^aAdverse events were coded based on preferred terms in the Medical Dictionary for Regulatory Activities version 22.0. Adverse events that led to > 2 dose reductions in either treatment group are shown. Percentages are based on the total number of dose reductions

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