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Table 6 Cumulative percent of patients with AEs (302/304 pooled population)

From: Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimer's disease

 

Placebo

Donepezil 5 mg

Donepezil 10 mg

 

1 week

2 weeks

4 weeks

Total duration

1 week

2 weeks

4 weeks

Total duration

1 week*

2 weeks

4 weeks

Total duration

Number (%) of subjects with at least 1 such AE

92 (21.1)

122 (28.0)

171 (39.2)

329 (75.5)

98 (23.1)

126 (29.6)

176 (41.4)

331 (77.9)

118 (27.4)

201 (48.1)

252 (58.6)

361 (84.0)

Number (%) of subjects who discontinued due to AE

8 (1.8)

11 (2.5)

14 (3.2)

27 (6.2)

5 (1.2)

8 (1.9)

10 (2.4)

20 (4.7)

9 (2.1)

24 (5.6)

38 (8.8)

65 (15.1)

   Vomiting

2 (0.5)

2 (0.5)

3 (0.7)

13 (3.0)

7 (1.6)

9 (2.1)

10 (2.4)

17 (4.0)

13 (3.0)

38 (8.8)

47 (10.9)

59 (13.7)

   Nausea

6 (1.4)

11 (2.5)

14 (3.2)

25 (5.7)

15 (3.5)

16 (3.8)

19 (4.5)

26 (6.1)

22 (5.1)

62 (14.4)

78 (18.1)

92 (21.4)

   Diarrhea

4 (0.9)

6 (1.4)

9 (2.1)

22 (5.0)

9 (2.1)

15 (3.5)

18 (4.2)

42 (9.9)

14 (3.3)

31 (7.2)

45 (10.5)

73 (17.0)

   Dizziness

4 (0.9)

8 (1.8)

10 (2.3)

21 (4.8)

8 (1.9)

14 (3.3)

15 (3.5)

28 (6.6)

9 (2.1)

20 (4.7)

26 (6.0)

38 (8.8)

   Headache

9 (2.1)

10 (2.3)

19 (4.4)

50 (11.5)

7 (1.6)

11 (2.6)

20 (4.7)

41 (9.6)

17 (4.0)

31 (7.2)

36 (8.4)

57 (13.3)

  1. *Patients received 5 mg per day during Week 1 and titrated to 10 mg/d on the first day of study Week 2.