Table 2.

Summary of TRAEs and TEAEs by systemic organ classification (safety analysis set)

System organ classification (SOC)	ADG1060.1 mg/kg, n = 1 n (%)	ADG1060.5 mg/kg, n = 3 n (%)	ADG1061.5 mg/kg, n = 5 n (%)	ADG1063.0 mg/kg, n = 14 n (%)	ADG1065.0 mg/kg, n = 36 n (%)	ADG10610.0 mg/kg, n = 3 n (%)	Total n = 62n(%)
≥3 grade TRAEs
At least one TRAE (≥3 grade)	0 (0)	0 (0)	0 (0)	2 (14.3)	9 (25.0)	2 (66.7)	13 (21.0)
Laboratory abnormality	0 (0)	0 (0)	0 (0)	2 (14.3)	8 (22.2)	1 (33.3)	11 (17.7)
Leukopenia	0 (0)	0 (0)	0 (0)	2(14.3)	5 (13.9)	1 (33.3)	8 (12.9)
Neutropenia	0 (0)	0 (0)	0 (0)	2(14.3)	4 (11.1)	1 (33.3)	7 (11.3)
Aspartate aminotransferase increased	0 (0)	0 (0)	0 (0)	0 (0)	2 (5.6)	0 (0)	2 (3.2)
Thrombocytopenia	0 (0)	0 (0)	0 (0)	0 (0)	2 (5.6)	0 (0)	2 (3.2)
Alanine aminotransferase increased	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Hematocrit decreased	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Conjugated bilirubin increased	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Blood bilirubin increased	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Blood and lymphatic system disorders	0 (0)	0 (0)	0 (0)	0 (0)	2 (5.6)	2 (66.7)	4 (6.5)
Hemolytic anemia	0 (0)	0 (0)	0 (0)	0 (0)	2 (5.6)	0 (0)	2 (3.2)
TRAEs resulting in drug withdrawal
Neutropenia	0 (0)	0 (0)	0 (0)	1 (7.1)	1 (2.8)	1 (33.3)	3 (4.8)
Blood bilirubin increased	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Hemolytic anemia	0 (0)	0 (0)	0 (0)	0 (0)	2 (5.6)	0 (0)	2 (3.2)
Infusion-related reaction	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Anemia	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (33.3)	1 (1.6)
Drug-related SAEs resulting in drug withdrawal
Neutropenia	0 (0)	0 (0)	0 (0)	1 (7.1)	1 (2.8)	1 (33.3)	3 (4.8)
Fever	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Hemolytic anemia	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Anemia	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	1 (33.3)	1 (1.6)
All TEAEs
≥3 grade TEAEs	0 (0)	1 (33.3)	1 (20.0)	4 (28.6)	16 (44.4)	2 (66.7)	24 (38.7)
Drug-related TEAEs	1 (100)	2 (66.7)	2 (40.0)	12 (85.7)	28 (77.8)	3 (100)	48 (77.4)
≥3 grade drug-related TEAEs	0 (0)	0 (0)	0 (0)	2 (14.3)	9 (25.0)	2 (66.7)	13 (21.0)
TEAEs resulting in drug withdrawal	0 (0)	0 (0)	0 (0)	2 (14.3)	7 (19.4)	2 (66.7)	11 (17.7)
TEAEs resulting in drug suspension/dose reduction	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	1 (33.3)	2 (3.2)
TEAEs resulting in death	0 (0)	0 (0)	0 (0)	0 (0)	1 (2.8)	0 (0)	1 (1.6)
Severe TEAEs (STEAEs)	0 (0)	0 (0)	1 (20.0)	2 (14.3)	6 (16.7)	2 (66.7)	11 (17.7)
STEAEs resulting in drug withdrawal	0 (0)	0 (0)	0 (0)	2 (14.3)	4 (11.1)	2 (66.7)	8 (12.9)
≥2 grade TEAEs during dose escalation treatment phase	0 (0)	2 (66.7)	2 (66.7)	0 (0)	2 (66.7)	2 (66.7)	8 (12.9)