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) 
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.

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