Table 2.

Treatment-emergent adverse events

	FTD/TPI				BSC
	N = 185				N = 9
	Any grade		Grade ≥3		Any grade		Grade ≥3
	AE	n (%)	AE	n (%)	AE	n (%)	AE	n (%)
Any	1 069	177 (95.7)	297	122 (65.9)	29	7 (77.8)	12	6 (66.7)
Blood and lymphatic system disorders
Neutropenia	105	51 (27.6)	61	34 (18.4)	0	0 (0.0)	0	0 (0.0)
Leukopenia	77	35 (18.9)	32	15 (8.1)	0	0 (0.0)	0	0 (0.0)
Anaemia	57	42 (22.7)	16	13 (7.0)	1	1 (11.1)	1	1 (11.1)
Gastrointestinal disorders
Diarrhoea	45	38 (20.5)	9	8 (4.3)	0	0 (0.0)	0	0 (0.0)
Abdominal pain	12	12 (6.5)	3	3 (1.6)	2	1 (11.1)	1	1 (11.1)
Ascites	16	10 (5.4)	6	3 (1.6)	1	1 (11.1)	1	1 (11.1)
Vomiting	32	25 (13.5)	2	2 (1.1)	1	1 (11.1)	0	0 (0.0)
Nausea	46	40 (21.6)	1	1 (0.5)	1	1 (11.1)	0	0 (0.0)
Constipation	21	20 (10.8)	0	0 (0.0)	0	0 (0.0)	0	0 (0.0)
General disorders and administration site conditions
Pain	10	9 (4.9)	5	5 (2.7)	2	2 (22.2)	0	0 (0.0)
Fatigue	52	40 (21.6)	4	4 (2.2)	3	2 (22.2)	1	1 (11.1)
General physical health deterioration	10	9 (4.9)	4	4 (2.2)	1	1 (11.1)	0	0 (0.0)
Oedema	21	18 (9.7)	2	2 (1.1)	0	0 (0.0)	0	0 (0.0)
Pyrexia	19	16 (8.6)	1	1 (0.5)	0	0 (0.0)	0	0 (0.0)
Infections and infestations
Infection	11	9 (4.9)	5	5 (2.7)	1	1 (11.1)	1	1 (11.1)
Metabolism and nutrition disorders
Decreased appetite	29	26 (14.1)	4	3 (1.6)	0	0 (0.0)	0	0 (0.0)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Neoplasm progression	25	25 (13.5)	21	21 (11.4)	1	1 (11.1)	1	1 (11.1)
Nervous system disorders
Polyneuropathy	10	10 (5.4)	1	1 (0.5)	0	0 (0.0)	0	0 (0.0)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	22	19 (10.3)	1	1 (0.5)	0	0 (0.0)	0	0 (0.0)
Skin and subcutaneous tissue disorders
Alopecia	12	12 (6.5)	0	0 (0.0)	0	0 (0.0)	0	0 (0.0)

AE, adverse event; BSC, best supportive care; FTD/TPI, trifluridine/tipiracil.