Table 3.

AEs during NTB treatment

Adverse events (AEs)	Total (n = 26)	NTB group (n = 15)	NTB + IS group (n = 11)	P
Diarrhea	14 (53.9)	9 (60.0)	5 (45.5)	0.692
Elevated liver enzymes	2 (7.7)	2 (13.3)	0 (0)	0.492
Nausea	1 (3.9)	0 (0)	1 (9.1)	0.423
Headache	1 (3.9)	0 (0)	1 (9.1)	0.423
Gastrointestinal perforation	1 (3.9)	0	1 (9.1)	0.423
Dose reduction	11 (42.3)	6 (40.0)	5 (45.5)	1.000
Reasons for dose reduction
Diarrhea	8 (30.8)	4 (26.7)	4 (36.4)	0.683
Elevated liver enzymes	2 (7.7)	2 (13.3)	0 (0)	0.492
Nausea	1 (3.9)	0	1 (9.1)	0.423
Discontinuation	0 (0)	0 (0)	0 (0)	―

Data are expressed as number (%). NTB: nintedanib; IS: immunosuppressive agents

For statistical analyses, *p < 0.05, **p < 0.01. P-value: Fisher’s exact test