Table 4.

Adverse events of special interest from any cause^§ (infused patients, N = 9)

	Patients (N = 9)
	All grades, n (%)	Grade 3, n (%)	Grade 4, n (%)
Cytokine release syndromea	6 (66.7)	1 (11.1)	1 (11.1)
Neurological eventsb	1 (11.1)	1 (11.1)	0
Cytopenias not resolved by day 28	7 (77.8)	6 (66.7)	1 (11.1)
Infections	4 (44.4)	0	0
Tumor lysis syndrome	1 (11.1)	0	1 (11.1)

AESI adverse event of special interest, MedDRA Medical Dictionary for Regulatory Activities

^§Occurring within 8 weeks of tisagenlecleucel infusion

^aCytokine release syndrome was graded using the Penn grading scale

^bThe neurological event reported in 1 patient was delirium. AESIs are based on grouped term consisting of MedDRA preferred term(s)