Table 3.
Grades 3-5 Adverse Events Observed on Southwest Oncology Group Protocol S0016
| Adverse Events(grade ≥ 3) | CHOP-R(n = 263) |
CHOP-RIT(n = 263) |
P | ||
|---|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | ||
| Neutropenia | 127 | 48 | 135 | 51 | .54 |
| Thrombocytopenia | 6 | 2 | 46 | 18 | < .0001 |
| Anemia | 7 | 3 | 8 | 3 | 1.00 |
| Infection | 61 | 23 | 45 | 17 | .10 |
| Febrile neutropenia | 42 | 16 | 26 | 10 | .05 |
| Gastrointestinal | 20 | 8 | 24 | 9 | .64 |
| Cardiovascular | 19 | 7 | 9 | 3 | .08 |
| Fatigue | 11 | 4 | 9 | 3 | .82 |
| Grade 4 nonhematologic | 14 | 5 | 11 | 4 | .68 |
| Treatment-related deaths | 1 | < 1 | 4 | 2 | .37 |
| Second malignancies | 23 | 9 | 22 | 8 | 1.00 |
| AML/MDS | 3 | 1 | 8 | 3 | .22 |
Abbreviations: AML/MDS, acute myeloid leukemia/myelodysplastic syndrome; CHOP-R, cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab; CHOP-RIT, cyclophosphamide, doxorubicin, vincristine, prednisone with tositumomab/iodine I-131 tositumomab radioimmunotherapy.