Table 2.

Adverse events of grade ≥3 of clinical interest per treatment group before crossover.

	Regorafenib, N = 23			Placebo, N = 14
	3	4	5	3	4	5
Blood and lymphatic system disorders
Febrile neutropenia	1* (4.3%)	1* (4.3%)	0	0	0	0
Leukopenia	1 (4.3%)	0	0	0	0	0
Lymphopenia	2 (8.7%)	0	0	0	0	0
Thrombocytopenia	2 (8.7%)	0	1 (4.3%)	0	0	0
Gastrointestinal disorders
Diarrhoea	3 (13.0%)	0	0	0	0	0
Stomatitis	1 (4.3%)	0	0	0	0	0
General disorders and administration site conditions
Asthenia	4 (17.4%)	0	0	0	0	0
Fever	1 (4.3%)	0	0	0	0	0
Mucositis	2* (8.7%)	0	0	0	0	0
Pain	5* (21.7%)	0	0	1 (7.1%)	1 (7.1%)	0
Hepatobiliary disorders
Hepatocellular injury	1 (4.3%)	0	0	0	0	0
Infections and infestations
Bronchitis	1 (4.3%)	0	0	0	0	0
Infection	0	0	1 (4.3%)	0	0	0
Investigations
Blood lactate dehydrogenase increased	0	1 (4.3%)	0	0	0	0
Metabolism and nutrition disorders
Hypophosphataemia	1* (4.3%)	0	0	0	0	0
Nervous system disorders
Paraplegia	0	0	0	1 (7.1%)	0	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2 (8.7%)	0	0	0	1 (7.1%)	0
Haemoptysis	1 (4.3%)	0	0	0	0	0
Pneumothorax	2* (8.7%)	0	0	0	0	0
Skin and subcutaneous tissue disorders
Hand and foot skin reaction	3 (13.0%)	0	0	0	0	0
Vascular disorders
Hypertension	1 (4.3%)	0	0	0	0	0

^*One patient had a related serious adverse event