Table 3. Summary of adverse eventsa reported in ⩾10% of patients in either treatment arm.

	Nintedanib (n=64)		Sunitinib (n=32)
MedDRA preferred term, n (%)	Any grade	Grade ⩾3	Any grade	Grade ⩾3
Patients with any serious AE	20 (31.3)	16 (25.0)	11 (34.4)	8 (25.0)
Patients with any AE	58 (90.6)	31 (48.4)	30 (93.8)	19 (59.4)
Type of AE
Diarrhoea	40 (62.5)	2 (3.1)	16 (50.0)	1 (3.1)
Nausea	24 (37.5)	0 (0.0)	11 (34.4)b	1 (3.1)
Fatigue	16 (25.0)	2 (3.1)	8 (25.0)	2 (6.3)
Vomiting	10 (15.6)	0	7 (21.9)	1 (3.1)
Decreased appetite	10 (15.6)	0	6 (18.8)	0
Increased GGT	8 (12.5)	7 (10.9)	1 (3.1)	1 (3.1)
Decreased weight	8 (12.5)	1 (1.6)	2 (6.3)	0
Stomatitisc	0	0	10 (31.3)	2 (6.3)
Hand–foot syndromec	0	0	10 (31.3)	0
Dyspepsiac	2 (3.1)	0	7 (21.9)	0
Anaemia	4 (6.3)	0	5 (15.6)	2 (6.3)
Hypertensionc	2 (3.1)	0	5 (15.6)	2 (6.3)
Hypothyroidismc	2 (3.1)	0	5 (15.6)	0
Constipation	5 (7.8)	0	4 (12.5)	0
Dysgeusia	3 (4.7)	0	4 (12.5)	0
Increased lipase	2 (3.1)	2 (3.1)	4 (12.5)	3 (9.4)
Dyspnoeac	1 (1.6)	0	4 (12.5)	0

Abbreviations: AE=adverse event; GGT=gamma-glutamyltransferase; MedDRA=Medical Dictionary for Regulatory Activities.

^aClassified by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

^bOne patient reported nausea, but their CTCAE grade was not recorded.

^cP<0.05 for comparison of any grade AEs based on χ²-tests or Suissa–Shuster exact tests as appropriate.