Table 3.
No major safety signals with Toca 511 & Toca FC in Phase 3 trial.
Most Common (≥5%) Treatment Emergent Adverse Events (TEAE) | Most Common (≥2%) Treatment Emergent Serious Adverse Events (TESAE) | |||||
---|---|---|---|---|---|---|
Grade 3-4 TEAE | Toca 511 & Toca FC (n=201) | SOC (n=199) | Grade 3-4 TESAE | Toca 511 & Toca FC (n=201) | SOC (n =199) | |
Aphasia | 16 (8.0%) | 7 (3.5%) | Brain Edema | 8 (4%) | 2 (1%) | |
Hemiparesis | 15 (7.5%) | 5 (2.5%) | Pulmonary Embolism | 7 (3.5%) | 5 (2.5%) | |
Headache | 13 (6.5%) | 10 (5%) | Seizure | 7 (3.5%) | 8 (4%) | |
Seizure | 8 (4.0%) | 11 (5.5%) | Hemiparesis | 6 (3%) | 1 (0.5%) | |
WBC decrease | 0 | 10 (5.0%) | Headache | 5 (2.5%) | 0 | |
TEAEs leading to treatment discontinuation | 2 (1%) | 5 (2.5%) | Vasogenic Cerebral Edema | 4 (2.0%) | 0 | |
TEAEs Leading to death | 6 (3%) | 3 (1.5%) | Fall | 4 (2.0%) | 1 (0.5%) | |
No Treatment Related AEs Resulted in death | Subdural Hematoma | 4 (2.0%) | 1 (0.5%) |