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Table 6 Number of subjects having adverse events from total visits and the adverse events categorized by severity in the study and control groups

From: Effect of phytosterols and inulin-enriched soymilk on LDL-cholesterol in Thai subjects: a double-blinded randomized controlled trial

  Number (%)   
  Study group (n = 116)a Control group (n = 120) Total (n = 236) RR [95 % CI] p-value
Subjects had adverse events, person 36 (31.0) 28 (23.3) 64 (27.12) 1.33 [0.87-2.03] 0.177b
Actual adverse events, event 65 (100) 51 (100) 116 (100)   
Serious adverse events      
 Bloating 0 (0) 1 (1.96) 1 (0.86)   
 Hepatitis 0 (0) 1 (1.96) 1 (0.86)   
 Severe diarrhea 1 (1.54) 1 (1.96) 2 (1.72)   
Non-serious adverse events      
 Bloating 50 (76.92) 33 (64.72) 83 (71.56)   
 Abdominal cramp 0 (0) 1 (1.96) 1 (0.86)   
 Nausea 0 (0) 4 (7.84) 4 (3.45)   
 Vomiting 1 (1.54) 1 (1.96) 2 (1.72)   
 Increase defecation 2 (3.08) 0 (0) 2 (1.72)   
 Diarrhea 4 (6.15) 4 (7.84) 8 (6.90)   
 Constipation 2 (3.08) 2 (3.92) 4 (3.45)   
 Other 5 (7.69) 3 (5.88) 8 (6.90)   
  1. a3 subjects loss to follow up before the week 2, 1 subject requested to withdraw due to pregnancy
  2. bPearson Chi-square