Table 2.
No. (%) of Patients (n = 9) | |||
---|---|---|---|
Adverse Event | Grade 3 | Grade 4 | Grade 5 |
Possibly related | |||
Central nervous system | |||
Intracranial hemorrhage | 1 (11%) | 0 (0%) | 0 (0%) |
Unrelated | |||
Central nervous system | |||
Ischemic stroke | 1 (11%) | 0 (0%) | 0 (0%) |
Brain edema, localized | 1 (11%) | 0 (0%) | 0 (0%) |
Epileptic seizure | 2 (22%) | 0 (0%) | 0 (0%) |
Hemiparesis | 2 (22%) | 0 (0%) | 0 (0%) |
Aphasia | 1 (11%) | 0 (0%) | 0 (0%) |
Meningitis | 1 (11%) | 0 (0%) | 0 (0%) |
Others | |||
Increased liver enzymes | 1 (11%) | 0 (0%) | 0 (0%) |
All Adverse Events (AEs; including Severe Adverse Events) CTCAE grade ≥3 from all evaluable patients according to their causal relationship to the study product and study-related procedures as evaluated by the Data and Safety Monitoring Board (DSMB) of the CAR2BRAIN study.