Grade 3 or higher nonhematologic induction toxicities occurring in more than 10% of all treated patients
| Toxicity . | ADE (n = 59) . | ADEP (n = 59) . | Total (n = 118) . | P . |
|---|---|---|---|---|
| Hyperbilirubinemia | 15 (25%) | 31 (53%) | 46 (39%) | .004 |
| Stomatitis | 4 (7%) | 15 (25%) | 19 (16%) | .01 |
| Anorexia | 4 (7%) | 14 (24%) | 18 (15%) | .02 |
| Esophagitis | 2 (3%) | 10 (17%) | 12 (10%) | .03 |
| Diarrhea | 5 (8%) | 14 (24%) | 19 (16%) | .04 |
| Skin | 4 (7%) | 12 (20%) | 16 (13%) | .06 |
| Malaise/fatigue | 8 (14%) | 17 (29%) | 25 (21%) | .07 |
| Blood urea nitrogen | 9 (15%) | 18 (31%) | 27 (23%) | .08 |
| Dysrhythmia | 5 (8%) | 11 (19%) | 16 (13%) | .18 |
| Hyperglycemia | 5 (8%) | 10 (17%) | 15 (13%) | .27 |
| Central nervous system | 5 (8%) | 10 (17%) | 15 (13%) | .27 |
| Dyspnea | 6 (10%) | 10 (17%) | 16 (13%) | .42 |
| Infection | 27 (46%) | 24 (41%) | 51 (43%) | .71 |
| Pulmonary edema | 8 (14%) | 10 (17%) | 18 (15%) | .80 |
| No. of patients with at least 1 toxicity grade 3 or higher | 52 (88%) | 54 (92%) | 106 (90%) | .76 |
| Toxicity . | ADE (n = 59) . | ADEP (n = 59) . | Total (n = 118) . | P . |
|---|---|---|---|---|
| Hyperbilirubinemia | 15 (25%) | 31 (53%) | 46 (39%) | .004 |
| Stomatitis | 4 (7%) | 15 (25%) | 19 (16%) | .01 |
| Anorexia | 4 (7%) | 14 (24%) | 18 (15%) | .02 |
| Esophagitis | 2 (3%) | 10 (17%) | 12 (10%) | .03 |
| Diarrhea | 5 (8%) | 14 (24%) | 19 (16%) | .04 |
| Skin | 4 (7%) | 12 (20%) | 16 (13%) | .06 |
| Malaise/fatigue | 8 (14%) | 17 (29%) | 25 (21%) | .07 |
| Blood urea nitrogen | 9 (15%) | 18 (31%) | 27 (23%) | .08 |
| Dysrhythmia | 5 (8%) | 11 (19%) | 16 (13%) | .18 |
| Hyperglycemia | 5 (8%) | 10 (17%) | 15 (13%) | .27 |
| Central nervous system | 5 (8%) | 10 (17%) | 15 (13%) | .27 |
| Dyspnea | 6 (10%) | 10 (17%) | 16 (13%) | .42 |
| Infection | 27 (46%) | 24 (41%) | 51 (43%) | .71 |
| Pulmonary edema | 8 (14%) | 10 (17%) | 18 (15%) | .80 |
| No. of patients with at least 1 toxicity grade 3 or higher | 52 (88%) | 54 (92%) | 106 (90%) | .76 |
Grade 5 events for the toxicities included 3 infections on the ADE arm and 7 infections and 1 hepatic toxicity on the ADEP arm.