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Table 8 Summary of AEs

From: Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer’s dementia: a randomized controlled trial

n (%)

BI 2 mg QD 

(n = 123)

BI 5 mg QD 

(n = 122)

BI 10 mg QD 

(n = 122)

BI 25 mg QD 

(n = 123)

Placebo QD 

(n = 120)

Total 

(n = 610)

Patients with any AE

57 (46.3)

64 (52.5)

55 (45.1)

62 (50.4)

54 (45.0)

292 (47.9)

Patients with severe AEs

3 (2.4)

3 (2.5)

3 (2.5)

2 (1.6)

4 (3.3)

15 (2.5)

Patients with investigator-defined drug-related AEs

19 (15.4)

20 (16.4)

22 (18.0)

24 (19.5)

19 (15.8)

104 (17.0)

Patients with AEs leading to discontinuation of the trial drug

5 (4.1)

7 (5.7)

4 (3.3)

2 (1.6)

2 (1.7)

20 (3.3)

Patients with AEs of special interest

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.8)

1 (0.2)

Patients with serious AEs

5 (4.1)

4 (3.3)

4 (3.3)

4 (3.3)

5 (4.2)

22 (3.6)

Fatal

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Immediately life-threatening

0 (0.0)

1 (0.8)

0 (0.0)

0 (0.0)

0 (0.0)

1 (0.2)

Disability/incapacity

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Required or prolonged hospitalization

5 (4.1)

3 (2.5)

3 (2.5)

4 (3.3)

1 (0.8)

16 (2.6)

Congenital anomaly or birth defect

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Other medically important serious events

0 (0.0)

1 (0.8)

1 (0.8)

0 (0.0)

4 (3.3)

6 (1.0)

Patients with other significant AEs (according to ICH E3)

3 (2.4)

6 (4.9)

3 (2.5)

2 (1.6)

1 (0.8)

15 (2.5)

Suicidal intent based on C-SSRS

n = 123a

n = 122a

n = 122a

n = 122a

n = 118a

n = 607a

Suicidal ideation (1–3)

3 (2.4)

1 (0.8)

2 (1.6)

2 (1.6)

3 (2.5)

11 (1.8)

Active suicidal ideation with intent (4–5)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Suicidal behavior (6–10)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

0 (0.0)

Self-injurious behavior without suicidal intent

0 (0.0)

1 (0.8)

2 (1.6)

0 (0.0)

1 (0.8)

4 (0.7)

Eye disorders

3 (2.4)

0 (0.0)

5 (4.1)

4 (3.3)

3 (2.5)

15 (2.5)

Hemoglobin decreased

0 (0.0)

1 (0.8)

1 (0.8)

6 (4.9)

0 (0.0)

8 (1.3)

  1. AE adverse event, C-SSRS Columbia-Suicide Severity Rating Scale, ICH International Conference on Harmonization, QD once daily
  2. aNumber of patients with a post-baseline C-SSRS