Comparison of grade 3 to 4 adverse events during postremission therapy
| Adverse event . | CALGB 10403 (N = 238) . | COG AALL0232 (N = 149) . | P* . |
|---|---|---|---|
| Allergic reaction | 0 | 2.0 | .056 |
| Anaphylaxis | 12.6 | 17.5 | .19 |
| Coagulation abnormalities | |||
| Decreased fibrinogen | 12.2 | 1.3 | <.001 |
| Prothrombin time | 0.4 | 0.7 | 1 |
| Partial thromboplastin time | 5.0 | 0.7 | .02 |
| Disseminated intravascular coagulation | 0 | 1.3 | .15 |
| Central nervous system hemorrhage | 0.8 | 0 | .53 |
| Thrombosis | 10.1 | 2.0 | .002 |
| Hepatic | |||
| Liver failure | 0 | 0 | 1 |
| Aspartate aminotransferase | 34.0 | 17.5 | .0004 |
| Alanine aminotransferase | 55.5 | 35.6 | .0001 |
| Bilirubin | 15.6 | 16.1 | .88 |
| Pancreatitis | 8.0 | 2.7 | .045 |
| Bone | |||
| Fracture | 0.8 | 0.7 | 1 |
| Osteonecrosis | 3.4 | 2.7 | .77 |
| Hyperglycemia | 19.3 | 10.7 | .025 |
| Neurologic | |||
| Central nervous system ischemia | 0 | 0 | NA |
| Confusion | 1.7 | 0.7 | .65 |
| Encephalopathy | 0 | 4.7 | .001 |
| Motor neuropathy | 6.3 | 14.8 | .006 |
| Sensory neuropathy | 18.5 | 10.1 | .025 |
| Seizure | 3.4 | 0 | .026 |
| Dysphasia | 2.9 | 4.0 | .56 |
| Somnolence | 1.3 | 1.3 | 1 |
| Febrile neutropenia | 49.2 | 40.9 | .11 |
| Infection | 38.7 | 55.0 | .002 |
| Adverse event . | CALGB 10403 (N = 238) . | COG AALL0232 (N = 149) . | P* . |
|---|---|---|---|
| Allergic reaction | 0 | 2.0 | .056 |
| Anaphylaxis | 12.6 | 17.5 | .19 |
| Coagulation abnormalities | |||
| Decreased fibrinogen | 12.2 | 1.3 | <.001 |
| Prothrombin time | 0.4 | 0.7 | 1 |
| Partial thromboplastin time | 5.0 | 0.7 | .02 |
| Disseminated intravascular coagulation | 0 | 1.3 | .15 |
| Central nervous system hemorrhage | 0.8 | 0 | .53 |
| Thrombosis | 10.1 | 2.0 | .002 |
| Hepatic | |||
| Liver failure | 0 | 0 | 1 |
| Aspartate aminotransferase | 34.0 | 17.5 | .0004 |
| Alanine aminotransferase | 55.5 | 35.6 | .0001 |
| Bilirubin | 15.6 | 16.1 | .88 |
| Pancreatitis | 8.0 | 2.7 | .045 |
| Bone | |||
| Fracture | 0.8 | 0.7 | 1 |
| Osteonecrosis | 3.4 | 2.7 | .77 |
| Hyperglycemia | 19.3 | 10.7 | .025 |
| Neurologic | |||
| Central nervous system ischemia | 0 | 0 | NA |
| Confusion | 1.7 | 0.7 | .65 |
| Encephalopathy | 0 | 4.7 | .001 |
| Motor neuropathy | 6.3 | 14.8 | .006 |
| Sensory neuropathy | 18.5 | 10.1 | .025 |
| Seizure | 3.4 | 0 | .026 |
| Dysphasia | 2.9 | 4.0 | .56 |
| Somnolence | 1.3 | 1.3 | 1 |
| Febrile neutropenia | 49.2 | 40.9 | .11 |
| Infection | 38.7 | 55.0 | .002 |
Data are presented as percentages.
NA, not applicable.
*χ2 or Fisher’s exact test.