Table 5.

NT comparison among CTCAE, mCRES, ASTCT, and FDA label

	Patients included in FDA label (N = 106)*	All patients (N = 111)†
	CTCAE, n (%)	CTCAE regrade, n (%)	mCRES, n (%)	ASTCT, n (%)
Grade 1/2	43 (40.6)	34 (30.6)	5 (4.5)	5 (4.5)
Grade 3	19 (17.9)	11 (9.9)	6 (5.4)	8 (7.2)
Grade 4		5 (4.5)	8 (7.2)	6 (5.4)
Total	62 (58.5)	50 (45.0)	19 (17.1)	19 (17.1)

^*One hundred six patients who received tisagenlecleucel (as of September 2017) were reported in the FDA label.

^†As of December 2017, 111 patients received tisagenlecleucel in JULIET.