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

Table 5 Number, intensity and consequences for trial drug of diarrhea adverse events among patients who experienced ≥ 1 diarrhea adverse event in the INBUILD trial

	Nintedanib (n = 238)	Placebo (n = 86)
Number of diarrhea events
1	112 (47.1)	70 (81.4)
2	46 (19.3)	11 (12.8)
3	42 (17.6)	2 (2.3)
≥ 4	38 (16.0)	3 (3.5)
Time to onset of first diarrhea event (days)
≤ 31	114 (47.9)	41 (47.7)
> 31 to ≤ 61	22 (9.2)	13 (15.1)
> 61 to ≤ 91	21 (8.8)	6 (7.0)
> 91 to ≤ 182	35 (14.7)	8 (9.3)
> 182	46 (19.3)	18 (20.9)
CTCAE grade of worst diarrhea event
1 (mild)	149 (62.6)	70 (81.4)
2 (moderate)	60 (25.2)	10 (11.6)
3 (severe)	29 (12.2)	6 (7.0)
≥ 4 (life-threatening/fatal)	0	0
Worst consequence of diarrhea event for trial drug^a
Dose reduction	59 (24.8)	3 (3.5)
Discontinued trial drug	21 (8.8)	1 (1.2)
Neither of above	158 (66.4)	82 (95.3)

CTCAE: Common Terminology Criteria for Adverse Events [26]. Adverse events reported between first trial drug intake and 28 days after last trial drug intake are shown. Median exposure to trial drug was 17.4 months in both groups. Data are n (% of patients who had ≥ 1 diarrhea adverse event and in whom additional information was collected)
^aDiscontinuation of trial drug was considered the worst consequence, followed by dose reduction

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