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Table 4 Overview of TEAEs (safety analysis set)

From: Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema

  ASP8232 (N = 32) ASP8232/ranibizumab (N = 33) Ranibizumab (N = 31)
n (%) E n (%) E n (%) E
Overall TEAEs 21 (65.6) 43 17 (51.5) 50 19 (61.3) 51
Ocular TEAEs 10 (31.3) 14 13 (39.4) 21 12 (38.7) 23
Systemic TEAEsa 17 (53.1) 29 13 (39.4) 29 15 (48.4) 28
Drug-related TEAEs 2 (6.3) 6 3 (9.1) 3 3 (9.7) 3
Drug-related ocular TEAEs 1 (3.1) 1 1 (3.0) 1 2 (6.5) 2
Drug-related systemic TEAEs 2 (6.3) 5 2 (6.1) 2 1 (3.2) 1
Serious TEAEs 3 (9.4) 3 1 (3.0) 1 3 (9.7) 3
TEAEs leading to permanent discontinuation of study drug 2 (6.3) 2 1 (3.0) 1 0 0
Drug-related TEAEs leading to permanent discontinuation of study drug 1 (3.1) 1 0 0 0 0
TEAEs reported in ≥ 5% of patients in any treatment group
System organ class
 Preferred term (MedDRA v15.1)
Endocrine disorders 0 2 (6.1) 0
 Hypothyroidism 0 2 (6.1) 0
Eye disorders 8 (25.0) 13 (39.4) 12 (38.7)
 Conjunctival hemorrhage 0 3 (9.1) 0
 Diabetic retinal edema 3 (9.4) 1 (3.0) 2 (6.5)
 Retinal aneurysm 0 0 2 (6.5)
 Retinal exudates 2 (6.3) 2 (6.1) 1 (3.2)
 Visual acuity reduced 0 2 (6.1) 1 (3.2)
 Vitreous floaters 1 (3.1) 2 (6.1) 1 (3.2)
 Vitreous hemorrhage 0 2 (6.1) 2 (6.5)
Gastrointestinal disorders 1 (3.1) 2 (6.1) 1 (3.2)
 Vomiting 0 2 (6.1) 0
Metabolism and nutrition disorders 3 (9.4) 3 (9.1) 3 (9.7)
 Worsening type 2 DM 2 (6.3) 3 (9.1) 0
  1. Data are presented as n (%)
  2. DM diabetes mellitus, E number of events, TEAEs treatment-emergent adverse events
  3. aSystemic TEAEs include all non-ocular TEAEs