Baseline characteristics of patients included in the final study cohort, n = 1155
| . | . | Asparaginase enzyme activity levels . | Toxicity* . | |||||
|---|---|---|---|---|---|---|---|---|
| . | . | Main groups . | Subgroups . | Measurable AEA . | ||||
| . | Cohort . | Inactivation (AEA = 0 IU/L) . | Measurable (AEA > 0 IU/L) . | Low levels (AEA = 1-99 IU/L) . | Therapeutic levels (AEA = 100-250 IU/L) . | High levels (AEA >250 IU/L) . | No AspTox . | AspTox . |
| Patients | 1155 | 200 | 955 | 82 | 543 | 330 | 795 | 160 |
| Sex Male Female | 624 (54.0%) 531 (46.0%) | 105 (52.5%) 95 (47.5%) | 519 (54.3%) 436 (45.7%) | 52 (63.4%) 30 (36.6%) | 301 (55.4%) 242 (44.6%) | 166 (50.3%) 164 (49.7%) | 437 (55.0%) 358 (45.0%) | 82 (51.3%) 78 (48.8%) |
| Age, median [IQR] 0-9 y 10-17 y | 4 [2-7] 963 (83.4%) 192 (16.6%) | 3 [2-6] 176 (88.0%) 24 (12.0%) | 4 [2-8] 787 (82.4%) 168 (17.6%) | 4 [3-8] 65 (79.3%) 17 (20.7%) | 4 [2-8] 436 (80.3%) 107 (19.7%) | 4 [2-7] 286 (86.7%) 44 (13.3%) | 4 [2-6] 691 (86.9%) 104 (13.1%) | 8 [4-12] 96 (60%) 64 (40%) |
| Risk group Standard risk Intermediate risk | 696 (60.3%) 459 (39.7%) | 110 (55.0%) 90 (45.0%) | 586 (61.4%) 369 (38.6%) | 49 (59.8%) 33 (40.2%) | 333 (61.3%) 210 (38.7%) | 204 (61.8%) 126 (38.2%) | 492 (61.9%) 303 (38.1%) | 94 (58.8%) 66 (41.2%) |
| Immunophenotype B-cell ALL T-cell ALL | 1066 (92.3%) 89 (7.7%) | 189 (94.5%) 11 (5.5%) | 877 (91.8%) 78 (8.2%) | 79 (96.3%) 3 (3.7%) | 496 (91.3%) 47 (8.7%) | 302 (91.5%) 28 (8.5%) | 735 (92.4%) 60 (7.6%) | 142 (88.8%) 18 (11.2%) |
| Median AEA (IQR) | 0 IU/L | 221 IU/L (138316 IU/L) | 221 IU/L (138316 IU/L) | 224 IU/L (149333 IU/L) | ||||
| . | . | Asparaginase enzyme activity levels . | Toxicity* . | |||||
|---|---|---|---|---|---|---|---|---|
| . | . | Main groups . | Subgroups . | Measurable AEA . | ||||
| . | Cohort . | Inactivation (AEA = 0 IU/L) . | Measurable (AEA > 0 IU/L) . | Low levels (AEA = 1-99 IU/L) . | Therapeutic levels (AEA = 100-250 IU/L) . | High levels (AEA >250 IU/L) . | No AspTox . | AspTox . |
| Patients | 1155 | 200 | 955 | 82 | 543 | 330 | 795 | 160 |
| Sex Male Female | 624 (54.0%) 531 (46.0%) | 105 (52.5%) 95 (47.5%) | 519 (54.3%) 436 (45.7%) | 52 (63.4%) 30 (36.6%) | 301 (55.4%) 242 (44.6%) | 166 (50.3%) 164 (49.7%) | 437 (55.0%) 358 (45.0%) | 82 (51.3%) 78 (48.8%) |
| Age, median [IQR] 0-9 y 10-17 y | 4 [2-7] 963 (83.4%) 192 (16.6%) | 3 [2-6] 176 (88.0%) 24 (12.0%) | 4 [2-8] 787 (82.4%) 168 (17.6%) | 4 [3-8] 65 (79.3%) 17 (20.7%) | 4 [2-8] 436 (80.3%) 107 (19.7%) | 4 [2-7] 286 (86.7%) 44 (13.3%) | 4 [2-6] 691 (86.9%) 104 (13.1%) | 8 [4-12] 96 (60%) 64 (40%) |
| Risk group Standard risk Intermediate risk | 696 (60.3%) 459 (39.7%) | 110 (55.0%) 90 (45.0%) | 586 (61.4%) 369 (38.6%) | 49 (59.8%) 33 (40.2%) | 333 (61.3%) 210 (38.7%) | 204 (61.8%) 126 (38.2%) | 492 (61.9%) 303 (38.1%) | 94 (58.8%) 66 (41.2%) |
| Immunophenotype B-cell ALL T-cell ALL | 1066 (92.3%) 89 (7.7%) | 189 (94.5%) 11 (5.5%) | 877 (91.8%) 78 (8.2%) | 79 (96.3%) 3 (3.7%) | 496 (91.3%) 47 (8.7%) | 302 (91.5%) 28 (8.5%) | 735 (92.4%) 60 (7.6%) | 142 (88.8%) 18 (11.2%) |
| Median AEA (IQR) | 0 IU/L | 221 IU/L (138316 IU/L) | 221 IU/L (138316 IU/L) | 224 IU/L (149333 IU/L) | ||||
Only patients with AEA >0 IU/L.