Grade 3 or 4 nonhematologic toxicities observed in at least 10% of patients in either arm and all grade 5 toxicities
Toxicity and grade . | No. receiving HiDAC alone (%) . | No. receiving MCT (%) . | P . |
|---|---|---|---|
| Infection | |||
| 3 | 78 (54) | 97 (65) | < .001 |
| 4 | 11 (8) | 19 (13) | |
| 5 | 1 (< 1) | 3 (1) | |
| Bilirubin | |||
| 3 | 11 (8) | 20 (13) | .005 |
| 4 | 5 (3) | 12 (8) | |
| Stomatitis | |||
| 3 | 3 (2) | 19 (13) | .002 |
| 4 | 1 (< 1) | 1 (< 1) | |
| Anorexia | |||
| 3 | 12 (8) | 24 (16) | < .001 |
| 4 | 0 (0) | 4 (3) | |
| Hyperglycemia | |||
| 3 | 7 (5) | 18 (12) | .009 |
| 4 | 1 (< 1) | 5 (3) | |
| Nausea | |||
| 3 | 10 (7) | 30 (20) | < .001 |
| Pain | |||
| 3 | 15 (10) | 12 (8) | .833 |
| 4 | 1 (< 1) | 1 (< 1) | |
| Malaise/fatigue | |||
| 3 | 9 (6) | 20 (13) | .741 |
| 4 | 6 (4) | 2 (1) | |
| Cardiac function | |||
| 3 | 1 (< 1) | 2 (1) | .870 |
| 4 | 1 (< 1) | 1 (< 1) | |
| 5 | 1 (< 1) | 0 (0) | |
| All categories, worst toxicity | |||
| 3 | 85 (59) | 79 (53) | < .001 |
| 4 | 21 (14) | 47 (32) | |
| 5 | 2 (1) | 3 (2) |
Toxicity and grade . | No. receiving HiDAC alone (%) . | No. receiving MCT (%) . | P . |
|---|---|---|---|
| Infection | |||
| 3 | 78 (54) | 97 (65) | < .001 |
| 4 | 11 (8) | 19 (13) | |
| 5 | 1 (< 1) | 3 (1) | |
| Bilirubin | |||
| 3 | 11 (8) | 20 (13) | .005 |
| 4 | 5 (3) | 12 (8) | |
| Stomatitis | |||
| 3 | 3 (2) | 19 (13) | .002 |
| 4 | 1 (< 1) | 1 (< 1) | |
| Anorexia | |||
| 3 | 12 (8) | 24 (16) | < .001 |
| 4 | 0 (0) | 4 (3) | |
| Hyperglycemia | |||
| 3 | 7 (5) | 18 (12) | .009 |
| 4 | 1 (< 1) | 5 (3) | |
| Nausea | |||
| 3 | 10 (7) | 30 (20) | < .001 |
| Pain | |||
| 3 | 15 (10) | 12 (8) | .833 |
| 4 | 1 (< 1) | 1 (< 1) | |
| Malaise/fatigue | |||
| 3 | 9 (6) | 20 (13) | .741 |
| 4 | 6 (4) | 2 (1) | |
| Cardiac function | |||
| 3 | 1 (< 1) | 2 (1) | .870 |
| 4 | 1 (< 1) | 1 (< 1) | |
| 5 | 1 (< 1) | 0 (0) | |
| All categories, worst toxicity | |||
| 3 | 85 (59) | 79 (53) | < .001 |
| 4 | 21 (14) | 47 (32) | |
| 5 | 2 (1) | 3 (2) |
A total of 145 and 149 patients who received HiDAC alone or MCT, respectively, are reported here. The P values are from Cochran-Mantel-Haenszel test of different row mean scores, using all grades of the toxicity.