Does TISAGENLECLEUCEL Cause Neurotoxicity? 411 Reports in FDA Database

Q: Does TISAGENLECLEUCEL cause Neurotoxicity?

411 reports of Neurotoxicity have been filed with the FDA for TISAGENLECLEUCEL, representing 9.7% of all TISAGENLECLEUCEL adverse event reports.

Q: How dangerous is Neurotoxicity from TISAGENLECLEUCEL?

Of 411 reports, 146 (35.5%) resulted in death and 155 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 411 reports of Neurotoxicity have been filed in association with TISAGENLECLEUCEL (KYMRIAH). This represents 9.7% of all adverse event reports for TISAGENLECLEUCEL.

411

Reports of Neurotoxicity with TISAGENLECLEUCEL

9.7%

of all TISAGENLECLEUCEL reports

146

Deaths

155

Hospitalizations

How Dangerous Is Neurotoxicity From TISAGENLECLEUCEL?

Of the 411 reports, 146 (35.5%) resulted in death, 155 (37.7%) required hospitalization, and 100 (24.3%) were considered life-threatening.