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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