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Table 3 Incidence of adverse events reported by more than 3 patients in the PLA-DON10 group over time (SAS)

From: Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial

 

PLA-DON10 group a

 

AE

Treatment-related AE b

AE

Week 16–28

Week 28-40

Week >40

36 weeks

36 weeks

( n =37)

( n =36)

( n =34)

( n =37)

( n =37)

n (%)

n (%)

Total number of incidents

26

7

0

33 (89.2)

22 (59.5)

Constipation

3

0

0

3 (8.1)

1 (2.7)

Diarrhea

3

0

0

3 (8.1)

2 (5.4)

Nasopharyngitis

6

3

4

13 (35.1)

0

Dizziness

3

0

0

3 (8.1)

2 (5.4)

Parkinsonism

2

1

0

3 (8.1)

3 (8.1)

  1. SAS, safety analysis set; AE, adverse event.
  2. aTreatment with 3 mg started at Week 16, and the dose was increased to 5 mg at Week 18 and to 10 mg at Week 24.
  3. bAEs for which a causal relation with the study drug was considered possible or probable.