The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer’s disease

Table 3 Participants experiencing one or more adverse events, by affected body system (all-subjects-treated cohort) ^a

Body system	Active product	Control product	P value^b
Total participants	264	260
Body as a whole	24 (9.1)	33 (12.7)	0.208
Back pain, leg pain, syncope	24 (9.1)	33 (12.7)	0.208
Central and peripheral nervous system disorders	27 (10.2)	21 (8.1)	0.450
Headache, dizziness	27 (10.2)	21 (8.1)	0.450
Gastrointestinal system disorders	41 (15.5)	38 (14.6)	0.808
Diarrhea, vomiting, nausea	41 (15.5)	38 (14.6)	0.808
Metabolic and nutritional disorders	19 (7.2)	19 (7.3)	>0.99
Vitamin D deficiency, hypercholesterolemia, hypokalemia	19 (7.2)	19 (7.3)	>0.99
Musculoskeletal system disorders	24 (9.1)	15 (5.8)	0.183
Arthralgia, fracture	24 (9.1)	15 (5.8)	0.183
Psychiatric disorders	32 (12.1)	43 (16.5)	0.170
Anxiety, agitation, depression, confusion	32 (12.1)	43 (16.5)	0.170
Respiratory system disorders	50 (18.9)	42 (16.2)	0.423
Pharyngitis, upper respiratory tract infection	50 (18.9)	42 (16.2)	0.423
Skin and appendage disorders	8 (3.0)	18 (6.9)	0.045
Pruritus, increased sweating	8 (3.0)	18 (6.9)	0.045
Urinary system disorders	25 (9.5)	19 (7.3)	0.432
Urinary tract infection, urinary incontinence	25 (9.5)	19 (7.3)	0.432
Other	20 (7.6)	27 (10.4)	0.287
Fall, surgical intervention

Data presented as number (%). ^aFor body systems where >5% of participants in either study group reported an event. If a participant experienced the same event more than once within the same body system, the participant was only counted once for the statistical analysis. Adverse events occurring in <5% of patients were: application site disorders, endocrine disorders, hearing and vestibular disorders, heart rate and rhythm disorders, liver and biliary system disorders, myocardial/endocardial/pericardial and valve disorders, neoplasm, platelet, bleeding and clotting disorders, red blood cell disorders, reproductive disorders (male), resistant mechanism disorders, special senses disorders, vascular (extracardiac) disorders, vision disorders, white cell and reticuloendothelial disorders. ^bFisher’s exact test.

ISSN: 1758-9193