Toxicity in CCG-2961 according to phase and treatment assignment
| Toxicity by phase . | Phase 1: all . | Phase 2 . | A vs B (P) . | Phase 3 . | CT vs BMT (P) . | ||
|---|---|---|---|---|---|---|---|
| Regimen A . | Regimen B . | CT . | BMT . | ||||
| Number | 899 | 367 | 369 | — | 449 | 135 | — |
| Median days (no.) of ANC less than 109/L | 38 | 55 | 46 | <.001 | 38 | — | — |
| Median days (no.) of platelets more than 50×109/L | 37 | 56 | 50 | .043 | 37 | — | — |
| Median hospital days, no. | 36 | 38 | 31 | <.001 | 26 | 43 | <.001 |
| Grades 3 and 4 | |||||||
| Bilirubin | 23% | 22% | 18% | .251 | 16% | 35% | <.001 |
| Diarrhea | 30% | 22% | 22% | .969 | 9% | 19% | <.001 |
| Nausea/emesis | 24% | 23% | 28% | .118 | 13% | 40% | <.001 |
| Mucositis | 34% | 32% | 27% | .132 | 10% | 61% | <.001 |
| Glucose | 15% | 12% | 13% | .844 | 9% | 17% | .012 |
| Pulmonary (f) | 19% | 12% | 15% | .248 | 10% | 16% | .088 |
| Potassium | 21% | 27% | 20% | .017 | 13% | 16% | .391 |
| Any | 79% | 81% | 77% | .189 | 64% | 91% | <.001 |
| Toxicity by phase . | Phase 1: all . | Phase 2 . | A vs B (P) . | Phase 3 . | CT vs BMT (P) . | ||
|---|---|---|---|---|---|---|---|
| Regimen A . | Regimen B . | CT . | BMT . | ||||
| Number | 899 | 367 | 369 | — | 449 | 135 | — |
| Median days (no.) of ANC less than 109/L | 38 | 55 | 46 | <.001 | 38 | — | — |
| Median days (no.) of platelets more than 50×109/L | 37 | 56 | 50 | .043 | 37 | — | — |
| Median hospital days, no. | 36 | 38 | 31 | <.001 | 26 | 43 | <.001 |
| Grades 3 and 4 | |||||||
| Bilirubin | 23% | 22% | 18% | .251 | 16% | 35% | <.001 |
| Diarrhea | 30% | 22% | 22% | .969 | 9% | 19% | <.001 |
| Nausea/emesis | 24% | 23% | 28% | .118 | 13% | 40% | <.001 |
| Mucositis | 34% | 32% | 27% | .132 | 10% | 61% | <.001 |
| Glucose | 15% | 12% | 13% | .844 | 9% | 17% | .012 |
| Pulmonary (f) | 19% | 12% | 15% | .248 | 10% | 16% | .088 |
| Potassium | 21% | 27% | 20% | .017 | 13% | 16% | .391 |
| Any | 79% | 81% | 77% | .189 | 64% | 91% | <.001 |
ANC indicates absolute neutrophil count; NS, not significant; SGPT, serum glutamic pyruvic transaminase; GI, gastrointestinal; BP, blood pressure; PTT, partial thromboplastin time; and —, not applicable.