Table 4.

TEAEs of special interest (safety set)

AEs of special interest of CRS or NEsLiso-cel (n = 92)
CRS, n (%)   
Any grade 45 (49) 
Grade 1 34 (37) 
Grade 2 10 (11) 
Grade 3 1 (1) 
Grade 4/5 
Median (range) time to onset, d 5.0 (1-63) 
Median (range) time to resolution, d 4.0 (1-16) 
NEs, n (%)   
Any grade 10 (11) 
Grade 1 4 (4) 
Grade 2 2 (2) 
Grade 3 4 (4) 
Grade 4/5 
Median (range) time to onset, d 11.0 (7-17) 
Median (range) time to resolution, d 4.5 (1-30) 
Clinical management of CRS and/or NEs, n (%)  
Tocilizumab, corticosteroids, or both 24 (26) 
Tocilizumab only 9 (10) 
Tocilizumab and corticosteroids 13 (14) 
Corticosteroids only 2 (2) 
Vasopressors 
AEs of special interest of CRS or NEsLiso-cel (n = 92)
CRS, n (%)   
Any grade 45 (49) 
Grade 1 34 (37) 
Grade 2 10 (11) 
Grade 3 1 (1) 
Grade 4/5 
Median (range) time to onset, d 5.0 (1-63) 
Median (range) time to resolution, d 4.0 (1-16) 
NEs, n (%)   
Any grade 10 (11) 
Grade 1 4 (4) 
Grade 2 2 (2) 
Grade 3 4 (4) 
Grade 4/5 
Median (range) time to onset, d 11.0 (7-17) 
Median (range) time to resolution, d 4.5 (1-30) 
Clinical management of CRS and/or NEs, n (%)  
Tocilizumab, corticosteroids, or both 24 (26) 
Tocilizumab only 9 (10) 
Tocilizumab and corticosteroids 13 (14) 
Corticosteroids only 2 (2) 
Vasopressors 
Other AEs of special interestLiso-cel (n = 92)SOC (n = 91)
Severe infections, n (%) 14 (15) 19 (21) 
Hypogammaglobulinemia, n (%) 10 (11) 3 (3) 
Grade ≥3 cytopenia at study d 64, n (%)  40 (43) 3 (3) 
Grade ≥3 neutropenia at study d 64  34 (37) 2 (2) 
Recovered to grade ≤2 within 35 d§  25 (74) 1 (100) 
Recovered to grade ≤2 within 62 d§  4 (12) 
Recovered to grade ≤2 by end of study§  4 (12) 
Grade ≥3 thrombocytopenia at study d 64  34 (37) 
Recovered to grade ≤2 within 35 d§  24 (73) 
Recovered to grade ≤2 within 62 d§  3 (9) 
Recovered to grade ≤2 by end of study§  1 (3) 
Grade ≥3 anemia at study d 64, n (%) 11 (12) 1 (1) 
Recovered to grade ≤2 within 35 d§  8 (73) 1 (100) 
Recovered to grade ≤2 within 62 d§  2 (18) 
Recovered to grade ≤2 by end of study§  
Other AEs of special interestLiso-cel (n = 92)SOC (n = 91)
Severe infections, n (%) 14 (15) 19 (21) 
Hypogammaglobulinemia, n (%) 10 (11) 3 (3) 
Grade ≥3 cytopenia at study d 64, n (%)  40 (43) 3 (3) 
Grade ≥3 neutropenia at study d 64  34 (37) 2 (2) 
Recovered to grade ≤2 within 35 d§  25 (74) 1 (100) 
Recovered to grade ≤2 within 62 d§  4 (12) 
Recovered to grade ≤2 by end of study§  4 (12) 
Grade ≥3 thrombocytopenia at study d 64  34 (37) 
Recovered to grade ≤2 within 35 d§  24 (73) 
Recovered to grade ≤2 within 62 d§  3 (9) 
Recovered to grade ≤2 by end of study§  1 (3) 
Grade ≥3 anemia at study d 64, n (%) 11 (12) 1 (1) 
Recovered to grade ≤2 within 35 d§  8 (73) 1 (100) 
Recovered to grade ≤2 within 62 d§  2 (18) 
Recovered to grade ≤2 by end of study§  

Graded per the Lee 2014 criteria.11 

Defined as investigator-identified neurological AEs related to liso-cel and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

Defined as grade ≥3 central laboratory results at 35 days after liso-cel infusion or after the start of the last chemotherapy in the SOC arm. Prolonged cytopenia was assessed at the study day 64 visit for patients in the liso-cel arm (35 days after liso-cel infusion) or 35 days after the start of the last cycle of chemotherapy, including high-dose chemotherapy, for patients in the SOC arm. A window of ±6 days around these target dates was considered; within this window, the closest central laboratory assessment to the target date was used, and in case 2 assessments within the same window were equidistant from the target date, the worst result was taken. Laboratory assessments performed after starting a new antineoplastic therapy were not considered for analysis.

§

In the liso-cel arm, poststudy day 64 laboratory results were available for 34, 33, and 11 patients with grade ≥3 neutropenia, thrombocytopenia, and anemia, respectively. In the SOC arm, poststudy day 64 laboratory results were available for 1, 0, and 1 patient with grade ≥3 neutropenia, thrombocytopenia, and anemia, respectively. Recovery to grade ≤2 cytopenia was assessed on days 35 and 62 days after the initial prolonged cytopenia assessment and at the end of the study.

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