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

Table 4 Incidence of gastrointestinal events ^a (SAS)

AE ^a	PLA-DON10	DON5-DON10	DON10-DON10	DON-DON10 ^b
AE ^a	( n =37)	( n =47)	( n =49)	( n =96)
Subjects with any gastrointestinal events, number (%)	12 (32.4)	15 (31.9)	15 (30.6)	30 (31.3)
Abdominal discomfort	0	1 (2.1)	1 (2.0)	2 (2.1)
Abdominal pain	0	2 (4.3)	0	2 (2.1)
Abdominal pain upper	2 (5.4)	0	0	0
Constipation	3 (8.1)	1 (2.1)	4 (8.2)	5 (5.2)
Diarrhea	3 (8.1)	2 (4.3)	4 (8.2)	6 (6.3)
Dyspepsia	2 (5.4)	0	0	0
Epigastric discomfort	1 (2.7)	0	0	0
Fecal incontinence	0	1 (2.1)	0	1 (1.0)
Functional gastrointestinal disorder	0	0	1 (2.0)	1 (1.0)
Gastric ulcer	0	0	1 (2.0)	1 (1.0)
Gastritis	2 (5.4)	1 (2.1)	0	1 (1.0)
Gastrointestinal disorder	0	0	1 (2.0)	1 (1.0)
Gastroesophageal reflux disease	0	2 (4.3)	1 (2.0)	3 (3.1)
Intestinal obstruction	0	1 (2.1)	0	1 (1.0)
Nausea	2 (5.4)	3 (6.4)	2 (4.1)	5 (5.2)
Proctalgia	0	1 (2.1)	0	1 (1.0)
Vomiting	1 (2.7)	1 (2.1)	1 (2.0)	2 (2.1)
Gastroenteritis	0	1 (2.1)	0	1 (1.0)
Decreased appetite	2 (5.4)	3 (6.4)	3 (6.1)	6 (6.3)

SAS, safety analysis set; AE, adverse events. ^a“Gastrointestinal events” included Preferred Terms (PTs) classified by the SOCs of “gastrointestinal disorders” (except for “dry mouth,” “inguinal hernia,” “dysphagia,” “toothache,” “food poisoning,” “dental caries,” “periodontal disease,” “salivary hypersecretion,” and “oral ulceration”) as well as “decreased appetite” and “gastroenteritis.
^bDON5-DON10 and DON10-DON10 groups.

ISSN: 1758-9193