Table 1.

Patient characteristics of the genotyped subcohort and the full cohort of the DFCI 05-001 trial

CharacteristicFull cohort (N = 794)Genotyped subcohort (n = 449)P
Age, y   .83 
 <10 593 (75) 332 (74)  
 ≥10 201 (25) 117 (26)  
Sex   .89 
 Male 441 (56) 252 (56)  
 Female 353 (44) 197 (44)  
Hispanic ethnicity, clinical*   .10 
 Hispanic 150 (21) 74 (17)  
 Non-Hispanic 582 (79) 375 (83)  
Race, clinical   .84 
 White 617 (78) 343 (76)  
 Black 40 (5) 20 (5)  
 Asian 23 (3) 15 (3)  
 Other/unknown 114 (14) 71 (16)  
Initial risk group   .25 
 Standard 462 (58) 277 (62)  
 High 332 (42) 172 (38)  
Random assignment   .93 
 Directly assigned IM E coli 281 (38) 175 (39)  
 IV PEG-asparaginase 232 (32) 131 (29)  
 IM E coli 231 (30) 139 (31)  
 Not assigned because of induction toxicity 5 (1) 3 (1)  
Final risk group   .84 
 Standard 407 (54) 248 (55)  
 High 260 (35) 156 (35)  
 Very high 66 (9) 45 (10)  
CharacteristicFull cohort (N = 794)Genotyped subcohort (n = 449)P
Age, y   .83 
 <10 593 (75) 332 (74)  
 ≥10 201 (25) 117 (26)  
Sex   .89 
 Male 441 (56) 252 (56)  
 Female 353 (44) 197 (44)  
Hispanic ethnicity, clinical*   .10 
 Hispanic 150 (21) 74 (17)  
 Non-Hispanic 582 (79) 375 (83)  
Race, clinical   .84 
 White 617 (78) 343 (76)  
 Black 40 (5) 20 (5)  
 Asian 23 (3) 15 (3)  
 Other/unknown 114 (14) 71 (16)  
Initial risk group   .25 
 Standard 462 (58) 277 (62)  
 High 332 (42) 172 (38)  
Random assignment   .93 
 Directly assigned IM E coli 281 (38) 175 (39)  
 IV PEG-asparaginase 232 (32) 131 (29)  
 IM E coli 231 (30) 139 (31)  
 Not assigned because of induction toxicity 5 (1) 3 (1)  
Final risk group   .84 
 Standard 407 (54) 248 (55)  
 High 260 (35) 156 (35)  
 Very high 66 (9) 45 (10)  

Data are No. (%).

IM, intramuscular.

*

Data on Hispanic ethnicity unknown for 62 patients.

Data on final risk group are missing for 61 patients.

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