Table 5.
Selected major toxic effects of treatment according to risk or age group at diagnosis
| Toxic effect | No. of patients | 3-y cumulative risk, % (95% CI) | P |
|---|---|---|---|
| Severe adverse events (grade 4 or 5) | |||
| All patients | 831 | 11.3 (10.6-12.0) | |
| Intermediate-risk or high-risk group | 545 | 15.4 (14.2-16.5) | <.001 |
| Low-risk group | 286 | 7.6 (6.7-8.5) | |
| Age <10 y | 630 | 9.9 (9.2-10.6) | <.001 |
| Age ≥10 y | 201 | 20.6 (18.0-23.2) | |
| Sepsis (grade 3, 4, or 5) | |||
| All patients | 1189 | 15.9 (15.1-16.7) | |
| Intermediate-risk or high-risk group | 768 | 21.3 (20.0-22.6) | <.001 |
| Low-risk group | 421 | 10.9 (9.9-11.9) | |
| Age <10 y | 984 | 15.2 (14.3-16.1) | <.001 |
| Age ≥10 y | 205 | 20.4 (17.9-22.9) | |
| Severe pneumonia (grade 3, 4, or 5) | |||
| All patients | 345 | 4.9 (4.4-5.4) | |
| Intermediate-risk or high-risk group | 193 | 5.7 (4.9-6.5) | .003 |
| Low-risk group | 152 | 4.1 (3.5-4.7) | |
| Age <10 y | 295 | 4.8 (4.3-5.3) | .50 |
| Age ≥10 y | 50 | 5.6 (4.1-7.1) | |
| Invasive fungal infection (grade 3, 4, or 5) | |||
| All patients | 340 | 4.6 (4.1-5.1) | |
| Intermediate-risk or high-risk group | 209 | 6.0 (5.5-6.5) | <.001 |
| Low-risk group | 131 | 3.4 (2.8-4.2) | |
| Age <10 y | 275 | 4.3 (3.8-4.8) | .001 |
| Age ≥10 y | 65 | 6.8 (5.2-8.4) | |
| Allergic reaction to asparaginase (grade 2, 3, or 4) | |||
| All patients | 315 | 4.2 (3.7-4.7) | |
| Intermediate-risk or high-risk group | 151 | 4.1 (3.5-4.7) | .95 |
| Low-risk group | 164 | 4.2 (3.6-4.8) | |
| Age <10 y | 287 | 4.4 (3.9-4.9) | .02 |
| Age ≥10 y | 28 | 2.8 (1.8-3.8) | |
| Pancreatitis (grade 3, 4, or 5) | |||
| All patients | 296 | 3.9 (3.5-4.3) | |
| Intermediate-risk or high-risk group | 211 | 5.8 (5.0-6.6) | <.001 |
| Low-risk group | 85 | 2.2 (1.7-2.7) | |
| Age <10 y | 211 | 3.2 (2.8-3.6) | <.001 |
| Age ≥10 y | 85 | 8.4 (6.7-10.1) | |
| Thrombosis (grade 3 or 4) | |||
| All patients | 157 | 2.1 (1.8-2.4) | |
| Intermediate-risk or high-risk group | 79 | 2.2 (1.7-2.7) | .62 |
| Low-risk group | 78 | 2.0 (1.6-2.4) | |
| Age <10 y | 128 | 1.9 (1.6-2.2) | .06 |
| Age ≥10 y | 29 | 2.9 (1.9-3.9) | |
| Tumor lysis syndrome (grade 3 or 4) | |||
| All patients | 141 | 1.8 (1.5-2.1) | |
| Intermediate-risk or high-risk group | 122 | 3.3 (2.7-3.9) | <.001 |
| Low-risk group | 19 | 0.5 (0.3-0.7) | |
| Age <10 y | 96 | 1.5 (1.2-1.8) | <.001 |
| Age ≥10 y | 45 | 4.4 (3.1-5.7) | |
| Seizure (grade 2, 3, or 4) | |||
| All patients | 86 | 1.2 (1.0-1.4) | |
| Intermediate-risk or high-risk group | 57 | 1.6 (1.2-2.0) | <.001 |
| Low-risk group | 29 | 0.8 (0.5-1.1) | |
| Age <10 y | 64 | 1.0 (0.8-1.2) | <.001 |
| Age ≥10 y | 22 | 2.2 (1.3-3.1) | |
| Osteonecrosis (grade 3 or 4) | |||
| All patients | 23 | 0.4 (0.2-0.6) | |
| Intermediate-risk or high-risk group | 18 | 0.6 (0.3-0.9) | <.001 |
| Low-risk group | 5 | 0.2 (0-0.4) | |
| Age <10 y | 6 | 0.1 (0-0.2) | <.001 |
| Age ≥10 y | 17 | 2.3 (1.2-3.4) |