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Table 3 Summary of adverse events (safety set)

From: Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study

Adverse events Be (n = 49) Bi (n = 100) BB (n = 49) Placebo (n = 99) P value
Events, n Participant, n (%) Events, n Participant, n (%) Events, n Participant, n (%) Events, n Participant, n (%)
Adverse events 111 40 (81.63) 203 84 (84.00) 118 40 (81.63) 239 82 (82.83) 0.973
Drug-related adverse events 19 9 (18.37) 30 21 (21.00) 28 15 (30.61) 37 26 (26.26) 0.430
Adverse events unrelated to the study drug 92 38 (77.55) 173 81 (81.00) 90 37 (75.51) 202 79 (79.80) 0.859
Adverse events leading to discontinuation 4 2 (4.08) 4 4 (4.00) 0 0 (0.00) 6 3 (3.03) 0.679
Severe adverse events 5 4 (8.16) 4 4 (4.00) 0 0 (0.00) 6 3 (3.03) 0.213
Hypoglycemia event 14  9 (18.37)  23  14 (14.00)  7 (14.29)  19  14 (14.14)  0.887 
Most frequent treat-related adverse events           
 Fecal abnormalities 5 3 (6.12) 12 8 (8.00) 7 6 (12.24) 12 9 (9.09)  
 Abdominal discomfort/digestive tract disease 9 5 (10.20) 7 6 (6.00) 14 9 (18.37) 8 7 (7.07)  
 Dental and oral disorders 0 0 (0.00) 0 0 (0.00) 1 1 (2.04) 1 1 (1.01)  
 Others 1 1 (2.04) 1 1 (1.00) 0 0 (0.00) 0 0 (0.00)  
 Upper respiratory tract infection 0 0 (0.00) 0 0 (0.00) 2 2 (4.08) 1 1 (1.01)  
 Changes in body weight 0 0 (0.00) 3 3 (3.00) 1 1 (2.04) 1 1 (1.01)  
 Dizziness 0 0 (0.00) 1 1 (1.00) 2 2 (4.08) 1 1 (1.01)  
 Trauma/arthropathy 0 0 (0.00) 1 1 (1.00) 0 0 (0.00) 0 0 (0.00)  
 Abnormal ECG/cardiac dysfunction 3 3 (6.12) 1 1 (1.00) 1 1 (2.04) 2 2 (2.02)  
 Blood routine/biochemistry/urinalysis 1 1 (2.04) 4 3 (3.00) 0 0 (0.00) 10 7 (7.07)  
 Hemorrhoids 0 0 (0.00) 0 0 (0.00) 0 0 (0.00) 1 1 (1.01)