Patient characteristics of the genotyped subcohort and the full cohort of the DFCI 05-001 trial
Characteristic . | Full 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) |
Characteristic . | Full 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) |