Table 2.

Treatment-related TEAEs occurring in >10% of patients in schedules 1 and 2, and in schedule 3

Schedules 1 and 2
	Cohort 1 (n = 1)	Cohort 2 (n = 1)	Cohort 3 (n = 1)	Cohort 4 (n = 3)	Cohort 5 (n = 7)	Cohort 6 (n = 4)	Cohort 7 (n = 3)	Cohort 8 (n = 5)	Cohort 9 (n = 9)	Total (N = 34)
Dose, mg/kg	0.45	0.9	1.8	3.6	5.4	4.8	5.4	7.2	9.6
Total number of treatment-related TEAEs, n	2	0	1	7	60	25	18	14	39	166
Patients with ≥1 treatment-related TEAE, n (%)	1 (100)	0	1 (100)	2 (67)	7 (100)	3 (75)	3 (100)	5 (100)	8 (89)	30 (88)
Blurred vision	0	0	0	0	4 (57)	1 (25)	2 (67)	2 (40)	8 (89)	17 (50)
Subretinal fluid	0	0	0	0	3 (43)	1 (25)	2 (67)	2 (40)	3 (33)	11 (32)
Nausea	0	0	0	1 (33)	1 (14)	1 (25)	2 (67)	0	1 (11)	6 (18)
Vomiting	0	0	0	1 (33)	0	0	1 (33)	1 (20)	2 (22)	5 (15)
QTc prolongation	0	0	0	0	1 (14)	0	0	0	4 (44)	5 (15)
Dermatitis acneiform	0	0	0	0	0	1 (25)	1 (33)	2 (40)	1 (11)	5 (15)
Fatigue	1 (100)	0	0	0	1 (14)	0	1 (33)	0	1 (11)	4 (12)
Headache	0	0	0	1 (33)	1 (14)	1 (25)	1 (33)	0	0	4 (12)

Schedule 3
	Cohort 1 (n = 3)		Cohort 2 (n = 3)	Cohort 3 (n = 9)		Cohort 4 (n = 3)	Cohort 5 (n = 6)		Cohort 6 (n = 3)	Total (N = 27)
Dose, mg/kg	3.6		4.8	6.4		7.2	11.3		11.3
Total number of treatment-related TEAEs, n	11		9	19		38	50		9	136
Patients with ≥1 treatment-related TEAE, n (%)	2 (67)		3 (100)	8 (89)		3 (100)	6 (100)		3 (100)	25 (93)
Blurred vision	0		0	3 (33)		1 (33)	4 (67)		1 (33)	9 (33)
Subretinal fluid	1 (33)		1 (33)	2 (22)		0	1 (17)		1 (33)	6 (22)
Diarrhea	0		1 (33)	1 (11)		2 (67)	2 (33)		0	6 (22)
Dermatitis acneiform	0		0	0		1 (33)	4 (67)		1 (33)	6 (22)
Infusion-related reaction	0		0	2 (22)		1 (33)	2 (33)		1 (33)	6 (22)
Retinal detachment	0		1 (33)	1 (11)		1 (33)	1 (17)		0	4 (15)
Macular edema	0		0	1 (11)		1 (33)	2 (33)		0	4 (15)
Photopsia	0		0	1 (11)		1 (33)	1 (17)		1 (33)	4 (15)
Vitreous floaters	2 (67)		0	0		0	1 (17)		0	3 (11)
Dyspepsia	0		0	1 (11)		1 (33)	1 (17)		0	3 (11)
QTc prolongation	0		0	0		0	1 (17)		2 (67)	3 (11)

QTc, corrected QT interval; TEAE, treatment-emergent adverse event.