Table 7.
Number (%) of patients with at least one TEAE with an incidence of ≥5% of patients in any treatment group – Safety Population
| MedDRA System Organ Class/Preferred Term | Hydromethylthionine 8 mg/day (n = 110) | Hydromethylthionine 200 mg/day (n = 108) |
| Patients Reporting at Least One Adverse Event | 88 (80.0%) | 103 (95.4%) |
| Gastrointestinal disorders | 28 (25.5%) | 42 (38.9%) |
| Diarrhea | 9 (8.2%) | 24 (22.2%) |
| Vomiting | 5 (4.5%) | 9 (8.3%) |
| Infections and infestations | 38 (34.5%) | 34 (31.5%) |
| Nasopharyngitis | 8 (7.3%) | 7 (6.5%) |
| Urinary tract infection | 13 (11.8%) | 14 (13.0%) |
| Injury, poisoning and procedural complications | 18 (16.4%) | 16 (14.8%) |
| Fall | 10 (9.1%) | 13 (12.0%) |
| Investigations | 17 (15.5%) | 34 (31.5%) |
| Blood folate decreased | 6 (5.5%) | 9 (8.3%) |
| White blood cells urine positive | 1 (0.9%) | 6 (5.6%) |
| Metabolism and nutrition disorders | 12 (10.9%) | 14 (13.0%) |
| Folate deficiency | 2 (1.8%) | 6 (5.6%) |
| Nervous system disorders | 33 (30.5%) | 27 (25.0%) |
| Headache | 8 (7.3%) | 5 (4.6%) |
| Psychiatric disorders | 29 (26.4%) | 31 (28.7%) |
| Agitation | 9 (8.2%) | 9 (8.3%) |
| Insomnia | 3 (2.7%) | 7 (6.5%) |
| Renal and urinary disorders | 25 (22.7%) | 28 (25.9%) |
| Dysuria | 0 | 6 (5.6%) |
| Pollakiuria | 3 (2.7%) | 10 (9.3%) |
| Urinary incontinence | 13 (11.8%) | 9 (8.3%) |
| Respiratory, thoracic and mediastinal disorders | 12 (10.9%) | 8 (7.4%) |
| Cough | 7 (6.4%) | 2 (1.9%) |