Table 1. Patient disposition of treatment-naïve patients with DME (safety set).

Disposition, n (%)	Treatment-naïve DME patients (N = 1,049*)
Patients with one eye treated during the study	677 (64.5)
Patient ongoing in the study at year 1	893 (85.1)
Patients who discontinued the study	156 (14.9)
Reasons for discontinuation
AEs	4 (0.4)
Abnormal laboratory values	0
Abnormal test procedure results	0
Unsatisfactory therapeutic effect	13 (1.2)
Subject’s condition no longer required study drug	16 (1.5)
Subject withdrew consent	12 (1.1)
Lost to follow-up	73 (7.0)
Administrative problems	5 (0.5)
Death	12 (1.1)
Pregnancy	0
Subject switched to anti-VEGF other than ranibizumab	19 (1.8)
Protocol deviation	2 (0.2)

The safety set consisted of patients in the enrolled set who were treated with at least 1 dose of ranibizumab during this study or prior to start of study and had at least 1 safety assessment after the first treatment.

*Patients with a baseline visit on or before 1 March, 2015 are included. Data missing for 14 patients from the total 1,063 enrolled treatment-naïve patients with DME.

Data collected until the last recorded follow-up date was used to perform the analyses.

For treatment-naïve eyes, the date of first on-study injection with ranibizumab was considered the baseline date.

AE, adverse event; DME, diabetic macular edema; VEGF, vascular endothelial growth factor