Adverse events grade ≥2 possibly related to TDZ
| Adverse event . | Grade . | Dose level I (n = 6) . | Dose level II (n = 4) . | Dose level III (n = 3) . | Total frequency of occurrence . | |||
|---|---|---|---|---|---|---|---|---|
| Frequency per cohort, n (%) . | Frequency of occurrence . | Frequency per cohort, n (%) . | Frequency of occurrence . | Frequency per cohort, n (%) . | Frequency of occurrence . | |||
| General | ||||||||
| Fatigue | 2 | 1 (16) | 1 | 0 (0) | 0 | 0 (0) | 0 | 1 |
| Urinary incontinence | 2 | 0 (0) | 0 | 1 (25) | 1 | 0 (0) | 0 | 1 |
| Neurological | ||||||||
| Gait disturbance | 2 | 0 (0) | 0 | 0 (0) | 0 | 1 (33) | 1 | 1 |
| Dizziness | 2 | 0 (0) | 0 | 0 (0) | 0 | 1 (33) | 1 | 1 |
| Depressed level of consciousness | 3 | 0 (0) | 0 | 0 (0) | 0 | 1 (33) | 1 | 1 |
| Cardiovascular | ||||||||
| QTc interval prolongation (481-500 ms) | 2 | 0 (0) | 0 | 2 (50) | 7 | 1 (33) | 2 | 9 |
| QTc Interval prolongation (≥501 ms on at least 2 separate ECGs) | 3 | 1 (16) | 1 | 0 (0) | 0 | 0 (0) | 0 | 1 |
| Adverse event . | Grade . | Dose level I (n = 6) . | Dose level II (n = 4) . | Dose level III (n = 3) . | Total frequency of occurrence . | |||
|---|---|---|---|---|---|---|---|---|
| Frequency per cohort, n (%) . | Frequency of occurrence . | Frequency per cohort, n (%) . | Frequency of occurrence . | Frequency per cohort, n (%) . | Frequency of occurrence . | |||
| General | ||||||||
| Fatigue | 2 | 1 (16) | 1 | 0 (0) | 0 | 0 (0) | 0 | 1 |
| Urinary incontinence | 2 | 0 (0) | 0 | 1 (25) | 1 | 0 (0) | 0 | 1 |
| Neurological | ||||||||
| Gait disturbance | 2 | 0 (0) | 0 | 0 (0) | 0 | 1 (33) | 1 | 1 |
| Dizziness | 2 | 0 (0) | 0 | 0 (0) | 0 | 1 (33) | 1 | 1 |
| Depressed level of consciousness | 3 | 0 (0) | 0 | 0 (0) | 0 | 1 (33) | 1 | 1 |
| Cardiovascular | ||||||||
| QTc interval prolongation (481-500 ms) | 2 | 0 (0) | 0 | 2 (50) | 7 | 1 (33) | 2 | 9 |
| QTc Interval prolongation (≥501 ms on at least 2 separate ECGs) | 3 | 1 (16) | 1 | 0 (0) | 0 | 0 (0) | 0 | 1 |