Table 2.

Safety outcomes summary.

n (%)	DS-6157a 1.6 mg/kg (n = 4)	DS-6157a 3.2 mg/kg (n = 4)	DS-6157a 4.8 mg/kg (n = 5)	DS-6157a 6.4 mg/kg (n = 13)	DS-6157a 9.6 mg/kg (n = 6)	DS-6157a 12.8 mg/kg (n = 2)	Total (n = 34)
Patients with any TEAE	4 (100.0)	4 (100.0)	5 (100.0)	13 (100.0)	6 (100.0)	2 (100.0)	34 (100.0)
TEAEs associated with drug discontinuation	0	0	0	3 (23.1)	3 (50.0)	0	6 (17.6)
TEAEs associated with dose interruption	0	0	0	0	0	1 (50.0)	1 (2.9)
TEAEs associated with dose reduction	0	0	0	0	0	2 (100.0)	2 (5.9)
TEAEs associated with death as outcome	0	0	0	1 (7.7)	0	0	1 (2.9)
Treatment-related SAE	0	0	0	1 (7.7)	2 (33.3)	1 (50.0)	4 (11.8)
Adverse events of special interest	0	0	0	4 (30.8)	1 (16.7)	0	5 (14.7)
ILD/pneumonitis	0	0	0	1 (7.7)	0	0	1 (2.9)
IRRs	0	0	0	3 (23.1)	1 (16.7)	0	4 (11.8)
DLTs (any grade by patient)	0	0	0	1 (7.7)	1 (16.7)	2 (100.0)	4 (11.8)
CTCAE maximum grade ≥3 treatment-related TEAEs	0	1 (25.0)	1 (20.0)	8 (61.5)	5 (83.3)	2 (100.0)	17 (50.0)
Anemia	0	1 (25.0)	1 (20.0)	3 (23.1)	1 (16.7)	1 (50.0)	7 (20.6)
Febrile neutropenia	0	0	0	0	1 (16.7)	1 (50.0)	2 (5.9)
Neutropenia	0	0	0	0	0	1 (50.0)	1 (2.9)
Intestinal perforation	0	0	0	0	1 (16.7)	0	1 (2.9)
Vomiting	0	0	0	0	0	1 (50.0)	1 (2.9)
Fatigue	0	0	0	1 (7.7)	0	1 (50.0)	2 (5.9)
Peripheral edema	0	0	0	0	0	1 (50.0)	1 (2.9)
Hepatic function abnormal	0	0	0	1 (7.7)	1 (16.7)	0	2 (5.9)
Pneumonia	0	0	0	0	0	1 (50.0)	1 (2.9)
IRR	0	0	0	1 (7.7)	0	0	1 (2.9)
Decreased lymphocyte count	0	0	0	1 (7.7)	0	0	1 (2.9)
Decreased neutrophil count	0	0	0	2 (15.4)	3 (50.0)	0	5 (14.7)
Decreased platelet count	0	0	0	3 (23.1)	4 (66.7)	1 (50.0)	8 (23.5)
Decreased white blood cell count	0	0	0	1 (7.7)	3 (50.0)	0	4 (11.8)
Muscular weakness	0	0	0	1 (7.7)	0	0	1 (2.9)
Renal disorder	0	0	0	0	1 (16.7)	0	1 (2.9)