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. Author manuscript; available in PMC: 2022 Sep 1.
Published in final edited form as: Expert Opin Biol Ther. 2021 May 6;21(9):1199–1214. doi: 10.1080/14712598.2021.1902982

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%)