Table 3.

AESI 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 AESI, n	0	0	0	0	0	3	5	5	16	29
Patients with ≥1 AESI, n (%)	0	0	0	0	0	1 (25)	3 (10)	5 (10)	8 (89)	17 (50)
Eye disorders, n (%)	0	0	0	0	0	1 (25)	3 (10)	5 (10)	8 (89)	17 (50)
Blurred vision	0	0	0	0	0	0	2 (67)	2 (40)	8 (89)	12 (35)
Subretinal fluid	0	0	0	0	0	1 (25)	2 (67)	2 (40)	3 (33)	8 (24)
Retinal edema	0	0	0	0	0	0	0	1 (20)	1 (11)	2 (6)
Vitreous floaters	0	0	0	0	0	0	1 (33)	0	1 (11)	2 (6)
Macular edema	0	0	0	0	0	0	0	0	1 (11)	1 (3)

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 AEs, n	4		2	11	14	16		3	50
Patients with ≥1 AE, n (%)	2 (67)		2 (67)	7 (78)	3 (100)	6 (100)		2 (67)	22 (82)
Eye disorders, n (%)	2 (67)		2 (67)	7 (78)	3 (100)	6 (100)		2 (67)	22 (82)
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)
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)
Retinal detachment	0		1 (33)	1 (11)	1 (33)	1 (17)		0	4 (15)
Vitreous floaters	2 (67)		0	0	0	1 (17)		0	3 (11)
Detachment of retinal pigment epithelium	0		0	0	1 (33)	1 (17)		1 (33)	1 (4)

AESI, adverse events of special interest.