Table 3

Treatment-emergent adverse events with stepwise dosing

Adverse events, n (%)Cohorts I + III (n = 23)
Any gradeGrade ≥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 gradeGrade ≥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.

Close Modal

or Create an Account

Close Modal
Close Modal