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.