Table 2. Most Common (≥5%) Treatment-Emergent Adverse Events.
Grade 3-4 TEAEs | No. (%) | |
---|---|---|
Toca 511 and Toca FC (n = 201) | Standard of care (n = 199) | |
Aphasia | 16 (8.0) | 7 (3.5) |
Hemiparesis | 15 (7.5) | 5 (2.5) |
Headache | 13 (6.5) | 10 (5.0) |
Seizure | 8 (4.0) | 11 (5.5) |
White blood cell count decreased | 0 (0) | 10 (5.0) |
TEAEs leading to treatment discontinuation | 2 (1.0) | 5 (2.5) |
TEAEs leading to death | 6 (3.0) | 3 (1.5) |
Abbreviations: TEAEs, treatment-emergent adverse events; Toca 511, vocimagene amiretrorepvec; Toca FC, flucytosine.