Table 3.
Most common treatment-emergent adverse events occurring in at least 2% of patients receiving LMTM that were greater than in the control group
| Control 4 mg LMTM twice a day (n=354) |
75 mg LMTM twice a day (n=267) |
125 mg LMTM twice a day (n=264) |
|
|---|---|---|---|
| At least one treatment-emergent adverse event | 296 (84%) | 224 (84%) | 229 (87%) |
| Blood and lymphatic system disorders | 17 (5%) | 29 (11%) | 25 (9%) |
| Anaemia | 10 (3%) | 22 (8%) | 15 (6%) |
| Gastrointestinal disorders | 87 (25%) | 105 (39%) | 111 (42%) |
| Diarrhoea | 33 (9%) | 63 (24%) | 67 (25%) |
| Nausea | 14 (4%) | 22 (8%) | 19 (7%) |
| Vomiting | 2 (1%) | 25 (9%) | 18 (7%) |
| Abdominal pain | 11 (4%) | 9 (3%) | 9 (3%) |
| Infections and infestations | 88 (25%) | 83 (31%) | 76 (29%) |
| Urinary tract infection | 29 (8%) | 29 (11%) | 26 (10%) |
| Investigations | 80 (23%) | 87 (33%) | 80 (30%) |
| Blood folate decreased | 21 (6%) | 18 (7%) | 19 (7%) |
| Weight decreased | 6 (2%) | 8 (3%) | 10 (4%) |
| Haemoglobin decreased | 2 (1%) | 12 (4%) | 7 (3%) |
| Metabolism and nutrition disorders | 47 (13%) | 49 (18%) | 36 (13%) |
| Folate deficiency | 11 (3%) | 10 (4%) | 15 (6%) |
| Nervous system disorders | 105 (30%) | 91 (34%) | 64 (24%) |
| Cognitive disorder | 6 (2%) | 6 (2%) | 6 (2%) |
| Renal and urinary disorders | 29 (8%) | 61 (23%) | 65 (25%) |
| Dysuria | 3 (1%) | 7 (3%) | 27 (10%) |
| Micturition urgency | 4 (1%) | 7 (3%) | 6 (2%) |
| Pollakiuria | 6 (2%) | 15 (6%) | 18 (7%) |
| Urinary incontinence | 9 (3%) | 18 (7%) | 12 (5%) |
| Respiratory, thoracic, and mediastinal disorders | 28 (8%) | 32 (12%) | 22 (8%) |
| Cough | 12 (3%) | 14 (5%) | 11 (4%) |
LMTM=leuco-methylthioninium bis(hydromethanesulfonate).