Toxicity of consolidation therapy
. | ICE . | IcE consolidation course 1 . | IcE consolidation course 2 . | IcE . | P . | P for trend* . |
|---|---|---|---|---|---|---|
| No. patients | 95 | 103 | 96 | 103 | NA | NA |
| Neutropenia less than 0.5 × 109/L, d | 17 | 5 | 8 | 13 | .0005 | — |
| Thrombocytopenia less than 50 × 109/L, d | 27 | 13 | 16 | 29 | .50 | — |
| Infections, %† | 79 | 50 | 59 | 75 | .30 | — |
| Fever lower than 38.0°C, d | 8 | 2 | 2 | 4 | < .0001 | — |
| Duration of therapeutic IV antibiotics, d | 19 | 7 | 9 | 15 | .0020 | — |
| Clinical bleeding, %‡ | 5 | 1 | 0 | 1 | .092 | .16 |
| CNS, % | 6 | 1 | 0 | 1 | .050 | .056 |
| Cerebellar, % | 3 | 0 | 0 | 0 | .11 | .0036 |
| Cardiac, % | 1 | 2 | 0 | 2 | .53 | .079 |
| Cutaneous, % | 3 | 1 | 0 | 1 | .28 | .26 |
| Ocular, % | 5 | 2 | 1 | 3 | .32 | .024 |
| Stomatitis, % | 15 | 6 | 3 | 7 | .059 | .0031 |
| Nausea and vomiting, % | 20 | 8 | 3 | 8 | .010 | .0013 |
| Diarrhea, % | 4 | 1 | 2 | 3 | .47 | .0001 |
| GIT, % | 5 | 2 | 1 | 3 | .31 | .0096 |
| Renal, % | 1 | 0 | 0 | 0 | .48 | .023 |
| Hepatic, bilirubin, % | 3 | 1 | 1 | 2 | .46 | .20 |
| Other, % | 5 | 2 | 1 | 3 | .32 | .81 |
. | ICE . | IcE consolidation course 1 . | IcE consolidation course 2 . | IcE . | P . | P for trend* . |
|---|---|---|---|---|---|---|
| No. patients | 95 | 103 | 96 | 103 | NA | NA |
| Neutropenia less than 0.5 × 109/L, d | 17 | 5 | 8 | 13 | .0005 | — |
| Thrombocytopenia less than 50 × 109/L, d | 27 | 13 | 16 | 29 | .50 | — |
| Infections, %† | 79 | 50 | 59 | 75 | .30 | — |
| Fever lower than 38.0°C, d | 8 | 2 | 2 | 4 | < .0001 | — |
| Duration of therapeutic IV antibiotics, d | 19 | 7 | 9 | 15 | .0020 | — |
| Clinical bleeding, %‡ | 5 | 1 | 0 | 1 | .092 | .16 |
| CNS, % | 6 | 1 | 0 | 1 | .050 | .056 |
| Cerebellar, % | 3 | 0 | 0 | 0 | .11 | .0036 |
| Cardiac, % | 1 | 2 | 0 | 2 | .53 | .079 |
| Cutaneous, % | 3 | 1 | 0 | 1 | .28 | .26 |
| Ocular, % | 5 | 2 | 1 | 3 | .32 | .024 |
| Stomatitis, % | 15 | 6 | 3 | 7 | .059 | .0031 |
| Nausea and vomiting, % | 20 | 8 | 3 | 8 | .010 | .0013 |
| Diarrhea, % | 4 | 1 | 2 | 3 | .47 | .0001 |
| GIT, % | 5 | 2 | 1 | 3 | .31 | .0096 |
| Renal, % | 1 | 0 | 0 | 0 | .48 | .023 |
| Hepatic, bilirubin, % | 3 | 1 | 1 | 2 | .46 | .20 |
| Other, % | 5 | 2 | 1 | 3 | .32 | .81 |
Percentage of patients in each consolidation arm experiencing WHO grades 3 and 4 nonhematologic toxicities, or median durations of hematologic toxicities as defined. NA indicates not applicable; —, trend not assessed; and IV, intravenous.
Significance of trend based on individual toxicity grades rather than grade 3 or 4 toxicities.
Percentage of patients with clinically or microbiologically proven infections.
Coded as none, petechiae, mild blood loss, gross blood loss, debilitating blood loss. Percentages reported correspond to gross or debilitating blood loss