Treatment-emergent adverse events with stepwise dosing
| Adverse events, n (%) . | Cohorts I + III (n = 23) . | |
|---|---|---|
| Any grade . | Grade ≥3 . | |
| Any adverse event | 23 (100.0) | 22 (95.7) |
| Events reported for >15% of patients (any grade) | ||
| Tremor | 11 (47.8) | 1 (4.3) |
| Pyrexia | 10 (43.5) | 1 (4.3) |
| Fatigue | 6 (26.1) | 0 (0.0) |
| Edema | 6 (26.1) | 0 (0.0) |
| Thrombocytopenia | 5 (21.7) | 4 (17.4) |
| Device-related infection | 5 (21.7) | 3 (13.0) |
| Pneumonia | 5 (21.7) | 3 (13.0) |
| Diarrhea | 5 (21.7) | 0 (0.0) |
| Leukopenia | 4 (17.4) | 4 (17.4) |
| C-reactive protein increased | 4 (17.4) | 3 (13.0) |
| Hyperglycemia | 4 (17.4) | 2 (8.7) |
| Blood glucose increased | 4 (17.4) | 2 (8.7) |
| Speech disorder | 4 (17.4) | 1 (4.3) |
| Cough | 4 (17.4) | 0 (0.0) |
| Back pain | 4 (17.4) | 0 (0.0) |
| Hypokalemia | 4 (17.4) | 0 (0.0) |
| Any neurologic event reported for >1 patient (any grade)* | 16 (69.6) | 5 (21.7) |
| Tremor | 11 (47.8) | 1 (4.3) |
| Speech disorder | 4 (17.4) | 1 (4.3) |
| Dizziness | 3 (13.0) | 1 (4.3) |
| Encephalopathy | 3 (13.0) | 2 (8.7) |
| Aphasia | 2 (8.7) | 2 (8.7) |
| Somnolence | 2 (8.7) | 1 (4.3) |
| Disorientation | 2 (8.7) | 1 (4.3) |
| Confusional state | 2 (8.7) | 0 (0.0) |
| Paresthesia | 2 (8.7) | 0 (0.0) |
| Adverse events, n (%) . | Cohorts I + III (n = 23) . | |
|---|---|---|
| Any grade . | Grade ≥3 . | |
| Any adverse event | 23 (100.0) | 22 (95.7) |
| Events reported for >15% of patients (any grade) | ||
| Tremor | 11 (47.8) | 1 (4.3) |
| Pyrexia | 10 (43.5) | 1 (4.3) |
| Fatigue | 6 (26.1) | 0 (0.0) |
| Edema | 6 (26.1) | 0 (0.0) |
| Thrombocytopenia | 5 (21.7) | 4 (17.4) |
| Device-related infection | 5 (21.7) | 3 (13.0) |
| Pneumonia | 5 (21.7) | 3 (13.0) |
| Diarrhea | 5 (21.7) | 0 (0.0) |
| Leukopenia | 4 (17.4) | 4 (17.4) |
| C-reactive protein increased | 4 (17.4) | 3 (13.0) |
| Hyperglycemia | 4 (17.4) | 2 (8.7) |
| Blood glucose increased | 4 (17.4) | 2 (8.7) |
| Speech disorder | 4 (17.4) | 1 (4.3) |
| Cough | 4 (17.4) | 0 (0.0) |
| Back pain | 4 (17.4) | 0 (0.0) |
| Hypokalemia | 4 (17.4) | 0 (0.0) |
| Any neurologic event reported for >1 patient (any grade)* | 16 (69.6) | 5 (21.7) |
| Tremor | 11 (47.8) | 1 (4.3) |
| Speech disorder | 4 (17.4) | 1 (4.3) |
| Dizziness | 3 (13.0) | 1 (4.3) |
| Encephalopathy | 3 (13.0) | 2 (8.7) |
| Aphasia | 2 (8.7) | 2 (8.7) |
| Somnolence | 2 (8.7) | 1 (4.3) |
| Disorientation | 2 (8.7) | 1 (4.3) |
| Confusional state | 2 (8.7) | 0 (0.0) |
| Paresthesia | 2 (8.7) | 0 (0.0) |
Includes selected adverse events in the Medical Dictionary for Regulatory Activities system organ classes for Nervous System Disorders and Psychiatric Disorders.