Table 3 Summary of adverse events (safety set)
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 | 14Â | 9 (18.37)Â | 23Â | 14 (14.00)Â | 7Â | 7 (14.29)Â | 19Â | 14 (14.14)Â | 0.887Â |
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) |  |