Table 3.

Treatment-emergent adverse events attributable to G47Δ according to severity grade, n = 19

Body system and adverse event, n (%)	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Patient number with any adverse event	2 (10.5)	10 (52.6)	5 (26.3)	2 (10.5)
General disorder
Fever	6 (31.6)	10 (52.6)	1 (5.3)	0 (0)	0 (0)
Gastrointestinal disorder
Vomiting	3 (15.8)	7 (36.8)	1 (5.3)	0 (0)	0 (0)
Nausea	5 (26.3)	5 (26.3)	0 (0)	0 (0)	0 (0)
Nervous system disorder
Seizure	0 (0)	3 (15.8)	0 (0)	0 (0)	0 (0)
Cerebral edema	2 (10.5)	1 (5.3)	0 (0)	0 (0)	0 (0)
Neuropathy–sensory	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
Headache	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
Blood
Anemia	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
Investigations
Lymphocyte count decreased	1 (5.3)	3 (15.8)	3 (15.8)	2 (10.5)	0 (0)
White blood cell count decreased	2 (10.5)	3 (15.8)	1 (5.3)	0 (0)	0 (0)
Neutrophil count decreased	0 (0)	2 (10.5)	1 (5.3)	0 (0)	0 (0)
Platelet count decreased	3 (15.8)	0 (0)	0 (0)	0 (0)	0 (0)
Bilirubin increased	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
γ-Glutamyl transpeptidase increased	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
PT-INR increased	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
Hypoalbuminemia	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)
Hyponatremia	1 (5.3)	0 (0)	0 (0)	0 (0)	0 (0)

CTCAE v.4.03 Japanese version was used to determine each grade. PT-INR, prothrombin time-international normalized ratio.