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Table 1 Summary of adverse events by system organ class

From: Further analyses of the safety of verubecestat in the phase 3 EPOCH trial of mild-to-moderate Alzheimer’s disease

System organ class

Number (%)

Treatment difference (95% CIa)

12 mg (N = 652)

40 mg (N = 652)

Placebo (N = 653)

12 mg vs. placebo

40 mg vs. placebo

Any

 ≥ 1 adverse event

582 (89.3)

601 (92.2)

533 (81.6)

7.64 (3.84, 11.48)

10.55 (6.96, 14.23)

Gastrointestinal

 Diarrhea

53 (8.1)

57 (8.7)

38 (5.8)

2.31 (− 0.46, 5.14)

2.92 (0.10, 5.81)

 Gastritis

11 (1.7)

9 (1.4)

3 (0.5)

1.23 (0.13, 2.59)

0.92 (− 0.14, 2.20)

Infections

 Conjunctivitis

5 (0.8)

13 (2.0)

4 (0.6)

0.15

1.38 (0.17, 2.84)

Injury

 Head injury

3 (0.5)

9 (1.4)

2 (0.3)

0.15

1.07 (0.10, 2.33)

 Skin abrasion

9 (1.4)

15 (2.3)

6 (0.9)

0.46 (− 0.78, 1.79)

1.38 (0.02, 2.95)

Investigations

 Weight decreased

42 (6.4)

42 (6.4)

20 (3.1)

3.38 (1.10, 5.81)

3.38 (1.10, 5.81)

Metabolism/nutrition

 Decreased appetite

16 (2.5)

29 (4.4)

16 (2.5)

0.00 (− 1.76, 1.77)

2.00 (0.02, 4.11)

Musculoskeletal and connective tissue

 Muscle spasms

9 (1.4)

16 (2.5)

6 (0.9)

0.46 (− 0.78, 1.79)

1.54 (0.15, 3.13)

 Pain in extremity

14 (2.1)

20 (3.1)

8 (1.2

0.92 (− 0.52, 2.49)

1.84 (0.29, 3.60)

Nervous system

 Dizziness

31 (4.8)

53 (8.1)

32 (4.9)

− 0.15 (− 2.53, 2.23)

3.23 (0.56, 5.99)

Psychiatric

 Anxiety

39 (6.0)

46 (7.1)

24 (3.7)

2.31 (− 0.02, 4.73)

3.38 (0.96, 5.93)

 Insomnia

35 (5.4)

29 (4.4)

20 (3.1)

2.31 (0.13, 4.60)

1.39 (− 0.70, 3.55)

 Sleep disorder

18 (2.8)

8 (1.2)

3 (0.5)

2.30 (1.04, 3.91)

0.77 (− 0.27, 2.00)

 Suicidal ideation

39 (6.0)

38 (5.8)

21 (3.2)

2.77 (0.51, 5.15)

2.61 (0.37, 4.98)

Renal and urinary

 Hypertonic bladder

2 (0.3)

7 (1.1)

1 (0.2)

0.15

0.92 (0.10, 2.06)

Skin and subcutaneous tissue

 Alopecia

1 (0.2)

7 (1.1)

0 (0.0)

0.15

1.07 (0.49, 2.20)

 Hair color changes

12 (1.8)

16 (2.5)

0 (0.0)

1.84 (1.06, 3.19)

2.45 (1.52, 3.95)

 Urticaria

14 (2.1)

12 (1.8)

3 (0.5)

1.69 (0.52, 3.16)

1.38 (0.26, 2.78)

  1. Data shown are for adverse events with incidence of ≥ 1% in one or more verubecestat groups and where the lower bound of the 95% confidence interval for the difference versus placebo is > 0 in at least one verubecestat group
  2. aConfidence intervals only produced for those comparisons for which at least one of the treatment groups (verubecestat or placebo) had an incidence ≥ 1%
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Alzheimer's Research & Therapy

ISSN: 1758-9193