Table 2.
Safety—common adverse events
| Adverse event grade | 1CT-107 (N = 80) |
Control DC (N = 43) |
||||
|---|---|---|---|---|---|---|
| Grade 2 | Grade 3 | Grade 4 | Grade 2 | Grade 3 | Grade 4 | |
| Nervous system disorders | 27 (33%) | 14 (17.5%) | 21 (48.8%) | 7 (16.3%) | ||
| Headache | 2 (2.5%) | 7 (16.3%) | ||||
| Convulsion | 7 (8.8%) | 4 (5.0%) | 6 (14.0%) | 1 (2.3%) | ||
| Hemiparesis | 4 (5.0%) | 2 (4.7%) | ||||
| Partial seizures | 5 (6.3%) | 1 (2.3%) | ||||
| General disorders and administration site conditions | 16 (20.0%) | 6 (7.5%) | 12 (27.9%) | 5 (11.6%) | ||
| Fatigue | 9 (11%) | 3 (3.8%) | 8 (18.6%) | 3 (7.0%) | ||
| Gastrointestinal disorders | 11 (13.8%) | 6 (14.0%) | ||||
| Nausea | 6 (7.5%) | 4 (9.3%) | ||||
| Musculoskeletal and connective tissue disorders | 10 (12.5%) | 1 (1.3%) | 8 (18.6%) | 3 (7.0%) | ||
| Muscular weakness | 2 (2.5%) | 3 (7.0%) | 3 (7.0%) | |||
| Investigations | 5 (6.3%) | 4 (5%) | 4 (9.3%) | 2 (4.7%) | ||
| Skin and subcutaneous tissue disorders | 7 (8.8%) | 7 (16.3%) | ||||
| Blood and lymphatic system disorders | 9 (11.3%) | 6 (7.5%) | 6 (14.0%) | 4 (9.3%) | ||
| Thrombocytopenia | 3 (3.8%) | 3 (7.0%) | ||||
| WBC decrease | 4 (5.0%) | |||||
| Infections | 13 (16.3%) | 2 (2.5%) | 11 (25.6%) | 3 (7.0%) | ||
| Urinary tract infection | 5 (6.3%) | 2 (4.7%) | ||||
| Upper respiratory tract infection | 3 (7.0%) | |||||
| Metabolism and nutrition disorders | 5 (6.3%) | 3 (3.8%) | 7 (16.3%) | 4 (9.3%) | ||
| Decreased appetite | 2 (2.5%) | 3 (7.0%) | ||||
| Psychiatric disorders | 9 (11.3%) | 6 (14.0%) | ||||
| Insomnia | 3 (3.8%) | 4 (9.3%) | ||||
| Injury and procedural complications | 9 (11.3%) | 4 (9.3%) | ||||
| Vascular disorders | 6 (7.5%) | 3 (7.0%) | ||||
| Reproductive system and breast disorders | 3 (7.0%) | |||||
NOTE: Adverse events by body system with an incidence >5%.