Adverse events and hematologic recovery during and after induction treatment
| . | Total (n = 383) . | SD-DN arm (n = 189) . | HD-DN arm (n = 194) . | P . |
|---|---|---|---|---|
| Adverse events,* no. (%) | ||||
| Allergy | 3 (0.8) | 3 (1.6) | 0 | .078 |
| Cardiovascular, arrhythmia | 0 | 0 | 0 | 0 |
| Cardiovascular, general | 1 (0.3) | 1 (0.5) | 0 | .310 |
| Coagulation | 1 (0.3) | 0 | 1 (0.5) | .323 |
| Dermatologic | 16 (4.2) | 9 (4.8) | 7 (3.6) | .573 |
| Gastrointestinal | 38 (9.9) | 17 (9.0) | 21 (10.8) | .549 |
| Hemorrhagic | 19 (5.0) | 11 (5.8) | 8 (4.1) | .445 |
| Hepatic | 39 (10.2) | 23 (12.2) | 16 (8.2) | .204 |
| Infectious | 291 (76.0) | 148 (78.3) | 143 (73.7) | .293 |
| Metabolic | 81 (21.1) | 38 (20.1) | 43 (22.2) | .622 |
| Neurologic | 5 (1.3) | 3 (1.6) | 2 (1.0) | .632 |
| Ophthalmologic | 3 (0.8) | 1 (0.5) | 2 (1.0) | .578 |
| Pain-causing | 16 (4.2) | 11 (5.8) | 5 (2.6) | .113 |
| Respiratory | 39 (10.2) | 24 (12.7) | 15 (7.7) | .108 |
| Renal | 5 (1.3) | 4 (2.1) | 1 (0.5) | .168 |
| Hematologic recovery | ||||
| Time to recovery, d, mean ± SD | ||||
| ANC > 500/μL | 29.0 ± 10.6 | 29.3 ± 10.8 | 28.6 ± 10.4 | .535 |
| PLT > 20 000/μL | 29.7 ± 10.7 | 29.9 ± 11.4 | 29.5 ± 10.1 | .733 |
| Transfusion requirements, mean ± SD | ||||
| RBC, units | 11.5 ± 13.2 | 12.1 ± 17.3 | 11.0 ± 7.3 | .395 |
| PLT, units | 94.3 ± 81.7 | 94.1 ± 90.2 | 94.4 ± 72.4 | .975 |
| Duration of antibiotics, d, mean ± SD | 30.0 ± 15.4 | 30.9 ± 16.4 | 29.1 ± 14.3 | .252 |
| . | Total (n = 383) . | SD-DN arm (n = 189) . | HD-DN arm (n = 194) . | P . |
|---|---|---|---|---|
| Adverse events,* no. (%) | ||||
| Allergy | 3 (0.8) | 3 (1.6) | 0 | .078 |
| Cardiovascular, arrhythmia | 0 | 0 | 0 | 0 |
| Cardiovascular, general | 1 (0.3) | 1 (0.5) | 0 | .310 |
| Coagulation | 1 (0.3) | 0 | 1 (0.5) | .323 |
| Dermatologic | 16 (4.2) | 9 (4.8) | 7 (3.6) | .573 |
| Gastrointestinal | 38 (9.9) | 17 (9.0) | 21 (10.8) | .549 |
| Hemorrhagic | 19 (5.0) | 11 (5.8) | 8 (4.1) | .445 |
| Hepatic | 39 (10.2) | 23 (12.2) | 16 (8.2) | .204 |
| Infectious | 291 (76.0) | 148 (78.3) | 143 (73.7) | .293 |
| Metabolic | 81 (21.1) | 38 (20.1) | 43 (22.2) | .622 |
| Neurologic | 5 (1.3) | 3 (1.6) | 2 (1.0) | .632 |
| Ophthalmologic | 3 (0.8) | 1 (0.5) | 2 (1.0) | .578 |
| Pain-causing | 16 (4.2) | 11 (5.8) | 5 (2.6) | .113 |
| Respiratory | 39 (10.2) | 24 (12.7) | 15 (7.7) | .108 |
| Renal | 5 (1.3) | 4 (2.1) | 1 (0.5) | .168 |
| Hematologic recovery | ||||
| Time to recovery, d, mean ± SD | ||||
| ANC > 500/μL | 29.0 ± 10.6 | 29.3 ± 10.8 | 28.6 ± 10.4 | .535 |
| PLT > 20 000/μL | 29.7 ± 10.7 | 29.9 ± 11.4 | 29.5 ± 10.1 | .733 |
| Transfusion requirements, mean ± SD | ||||
| RBC, units | 11.5 ± 13.2 | 12.1 ± 17.3 | 11.0 ± 7.3 | .395 |
| PLT, units | 94.3 ± 81.7 | 94.1 ± 90.2 | 94.4 ± 72.4 | .975 |
| Duration of antibiotics, d, mean ± SD | 30.0 ± 15.4 | 30.9 ± 16.4 | 29.1 ± 14.3 | .252 |
ANC indicates absolute neutrophil count; PLT, platelets; and RBC, red blood cells.
Grade 3 or higher by NCI CTCAE Version 3.0.