Table 2.

Summary of deaths in patients who died within 6 months of randomization, in the ITT population

Parameter, n (%)Ide-cel (n = 254)SRs (n = 132)
Patients who died within 6 mo of randomization 30 (12) 9 (7) 
Primary cause of death   
Death from AE (not otherwise specified) 8 (3) 3 (2) 
Death from malignant disease or its complication 18 (7) 6 (5) 
Death from other cause  4 (2) 
Patients who did not receive study treatment and died 17 (7) 
Primary cause of death   
Death from AE (not otherwise specified) 3 (1) 
Death from malignant disease or its complication 13 (5) 
Death from other cause 1 (<1) 
Patients who received study treatment and died 13 (5) 9 (7) 
Primary cause of death   
Death from AE (not otherwise specified) 5 (2) 3 (2) 
Death from malignant disease or its complication 5 (2) 6 (5) 
Death from other cause 3 (1) 
Parameter, n (%)Ide-cel (n = 254)SRs (n = 132)
Patients who died within 6 mo of randomization 30 (12) 9 (7) 
Primary cause of death   
Death from AE (not otherwise specified) 8 (3) 3 (2) 
Death from malignant disease or its complication 18 (7) 6 (5) 
Death from other cause  4 (2) 
Patients who did not receive study treatment and died 17 (7) 
Primary cause of death   
Death from AE (not otherwise specified) 3 (1) 
Death from malignant disease or its complication 13 (5) 
Death from other cause 1 (<1) 
Patients who received study treatment and died 13 (5) 9 (7) 
Primary cause of death   
Death from AE (not otherwise specified) 5 (2) 3 (2) 
Death from malignant disease or its complication 5 (2) 6 (5) 
Death from other cause 3 (1) 

All 4 cases of “death from other cause” in the ide-cel arm were reported verbatim as “unknown,” which was coded under the system organ class of “general disorder and administration site condition.”

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