Summary of adverse events occurring in 5% or more of patients in either group
| GD-11 160 mg (n=80) | GD-11 80 mg (n=79) | Placebo (n=80) | P value | |
| Constipation | 13 (16.3%) | 18 (22.8%) | 13 (16.3%) | 0.4937 |
| Cerebral infarction | 4 (5.0%) | 7 (8.9%) | 2 (2.5%) | 0.1860 |
| Hypoproteinaemia | 7 (8.8%) | 7 (8.9%) | 6 (7.5%) | 0.9582 |
| Hypokalaemia | 10 (12.5%) | 6 (7.6%) | 9 (11.3%) | 0.6450 |
| Fever | 2 (2.5%) | 7 (8.9%) | 4 (5.0%) | 0.1860 |
| Abdominal discomfort | 1 (1.3%) | 3 (3.8%) | 4 (5.0%) | 0.4535 |
| Diarrhoea | 0 (0.0%) | 4 (5.1%) | 4 (5.0%) | 0.1230 |
| Abnormal liver function | 8 (10.0%) | 10 (12.7%) | 8 (10.0%) | 0.8402 |
| Infectious pneumonia | 1 (1.3%) | 5 (6.3%) | 0 (0.0%) | 0.0185 |
| Hyperuricaemia | 3 (3.8%) | 6 (7.6%) | 4 (5.0%) | 0.5245 |
| Hyperhomocysteinaemia | 10 (12.5%) | 4 (5.1%) | 11 (13.8%) | 0.1577 |
| Hyperlipidaemia | 4 (5.0%) | 6 (7.6%) | 7 (8.8%) | 0.6699 |
| Anxiety | 3 (3.8%) | 6 (7.6%) | 4 (5.0%) | 0.5245 |
| Progressive apoplexy | 2 (2.5%) | 4 (5.1%) | 1 (1.3%) | 0.3161 |
| Carotid arteriosclerosis | 1 (1.3%) | 2 (2.5%) | 4 (5.0%) | 0.4125 |
| Cough | 3 (3.8%) | 4 (5.1%) | 4 (5.0%) | 0.9314 |
| Urinary tract infection | 4 (5.0%) | 3 (3.8%) | 15 (18.8%) | 0.0026 |
| Anaemia | 2 (2.5%) | 6 (7.6%) | 2 (2.5%) | 0.1865 |
| Upper respiratory tract infection | 7 (8.8%) | 6 (7.6%) | 3 (3.8%) | 0.4715 |
| Renal impairment | 2 (2.5%) | 4 (5.1%) | 3 (3.8%) | 0.6470 |
| Insomnia | 8 (10.0%) | 9 (11.4%) | 5 (6.3%) | 0.5262 |
| Anorexia | 0 (0.0%) | 1 (1.3%) | 4 (5.0%) | 0.0900 |
| Sleep disorder | 3 (3.8%) | 2 (2.5%) | 4 (5.0%) | 0.9113 |
| Poor sleep quality | 2 (2.5%) | 4 (5.1%) | 4 (5.0%) | 0.7227 |
| Giddy | 5 (6.3%) | 4 (5.1%) | 4 (5.0%) | 1.0000 |
| Vitamin B12 deficiency | 0 (0.0%) | 5 (6.3%) | 2 (2.5%) | 0.0361 |
| Toothache | 1 (1.3%) | 0 (0.0%) | 4 (5.0%) | 0.1306 |