Table 3.

Summary of treatment-related adverse events occurring in the safety set population.

Event	GV1001 (N = 75)	Control (N = 67)
Adverse event led to death, no (%)	2 (2.7)	4 (6.0)
P value	0.421
Adverse event led to discontinuation, no (%)	12 (16.0)	13 (19.4)
P value	0.595
Adverse event with Grade ≥ 3, no (%)	58 (77.3)	49 (73.1)
P value	0.562
Haematologic adverse event with Grade ≥ 3, no (%)
Neutropenia	43 (57.3)	34 (50.8)
Febrile neutropenia	1(1.3)	1 (1.5)
Thrombocytopenia	7 (9.3)	9 (13.4)
Anaemia	12 (16.0)	9 (13.4)
Leukopenia	9 (12.0)	6 (9.0)
Non-haematologic adverse event with Grade ≥ 3, no (%)*
Blood bilirubin increased	1 (1.33)	6 (8.96)
Gamma-glutamyltransferase increased	1 (1.33)	2 (2.99)
Nausea	2 (2.67)	0 (0.00)
Stomatitis	1 (1.33)	2 (2.99)
Duodenal obstruction	3 (4.00)	0 (0.00)
Asthenia	5 (6.67)	2 (2.99)
Palmar-plantar erythrodysesthesia syndrome	2 (2.67)	2 (2.99)
Decreased appetite	2 (2.67)	0 (0.00)
Hyperglycaemia	2 (2.67)	0 (0.00)
Pulmonary embolism	2 (2.67)	1 (1.49)
Hypotension	4 (5.33)	0 (0.00)
Acute kidney injury	3 (4.00)	0 (0.00)
Chronic kidney disease	0 (0.00)	2 (2.99)

^*Occurred in ≥ 2 patients in either group.