Toxicity in CCG-2961 according to period of enrollment
| Toxicity before and after suspension . | Phase 1 . | Phase 2 . | ||||
|---|---|---|---|---|---|---|
| Before . | After . | P . | Before . | After . | P . | |
| N | 495 | 404 | — | — | — | — |
| Grades 3 and 4 | ||||||
| Any liver toxicity | — | — | NS | 23.1% | 30.4% | .032 |
| SGPT | 7.9% | 14.1% | .004 | 8.6% | 17.3% | <.001 |
| Glucose | 11.3% | 18.8% | .002 | 9.6% | 15.8% | .015 |
| Any GI toxicity | — | — | NS | 49.9% | 58.4% | .026 |
| Nausea/emesis | 20.6% | 28.2% | .010 | 21.4% | 30.7% | .005 |
| Systolic BP | 5.9% | 2.5% | .021 | — | — | NS |
| Fibrinogen | 3.6% | 7.7% | .012 | — | — | NS |
| PTT | 1.8% | 5.0% | .014 | — | — | NS |
| Calcium | 4.8% | 9.7% | .007 | 1.7% | 6.1% | .003 |
| Fever | 8.9% | 5.2% | .046 | — | — | NS |
| Any toxicity | 77.2% | 80.9% | .195 | — | — | NS |
| Hospital days | ||||||
| Mean | 35.7 | 38.8 | <.001 | 34.2 | 39.6 | <.001 |
| Median | 35 | 37 | <.001 | 33 | 36 | — |
| ICU days | ||||||
| Mean | 4.5 | 4.6 | .875 | 3.1 | 3.3 | .683 |
| Median | 0 | 0 | .799 | 0 | 0 | — |
| Toxicity before and after suspension . | Phase 1 . | Phase 2 . | ||||
|---|---|---|---|---|---|---|
| Before . | After . | P . | Before . | After . | P . | |
| N | 495 | 404 | — | — | — | — |
| Grades 3 and 4 | ||||||
| Any liver toxicity | — | — | NS | 23.1% | 30.4% | .032 |
| SGPT | 7.9% | 14.1% | .004 | 8.6% | 17.3% | <.001 |
| Glucose | 11.3% | 18.8% | .002 | 9.6% | 15.8% | .015 |
| Any GI toxicity | — | — | NS | 49.9% | 58.4% | .026 |
| Nausea/emesis | 20.6% | 28.2% | .010 | 21.4% | 30.7% | .005 |
| Systolic BP | 5.9% | 2.5% | .021 | — | — | NS |
| Fibrinogen | 3.6% | 7.7% | .012 | — | — | NS |
| PTT | 1.8% | 5.0% | .014 | — | — | NS |
| Calcium | 4.8% | 9.7% | .007 | 1.7% | 6.1% | .003 |
| Fever | 8.9% | 5.2% | .046 | — | — | NS |
| Any toxicity | 77.2% | 80.9% | .195 | — | — | NS |
| Hospital days | ||||||
| Mean | 35.7 | 38.8 | <.001 | 34.2 | 39.6 | <.001 |
| Median | 35 | 37 | <.001 | 33 | 36 | — |
| ICU days | ||||||
| Mean | 4.5 | 4.6 | .875 | 3.1 | 3.3 | .683 |
| Median | 0 | 0 | .799 | 0 | 0 | — |
NS indicates not significant; and —, not applicable.