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

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

Body system Active product Control product P valueb
Total participants 264 260  
Body as a whole 24 (9.1) 33 (12.7) 0.208
 Back pain, leg pain, syncope
Central and peripheral nervous system disorders 27 (10.2) 21 (8.1) 0.450
 Headache, dizziness
Gastrointestinal system disorders 41 (15.5) 38 (14.6) 0.808
 Diarrhea, vomiting, nausea
Metabolic and nutritional disorders 19 (7.2) 19 (7.3) >0.99
 Vitamin D deficiency, hypercholesterolemia, hypokalemia
Musculoskeletal system disorders 24 (9.1) 15 (5.8) 0.183
 Arthralgia, fracture
Psychiatric disorders 32 (12.1) 43 (16.5) 0.170
 Anxiety, agitation, depression, confusion
Respiratory system disorders 50 (18.9) 42 (16.2) 0.423
 Pharyngitis, upper respiratory tract infection
Skin and appendage disorders 8 (3.0) 18 (6.9) 0.045
 Pruritus, increased sweating
Urinary system disorders 25 (9.5) 19 (7.3) 0.432
 Urinary tract infection, urinary incontinence
Other 20 (7.6) 27 (10.4) 0.287
 Fall, surgical intervention    
  1. 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.