Adverse events
| Event . | Non-ITT HD-MTX (N = 130) . | ITT HD-MTX (N = 128) . | P* . | ||
|---|---|---|---|---|---|
| Any grade . | Grade 3 or 4 . | Any grade . | Grade 3 or 4 . | ||
| Hematologic toxicity | |||||
| Leukopenia | 85 (65.4) | 63 (48.5) | 89 (69.5) | 71 (55.5) | .316 |
| Neutropenia | 89 (68.5) | 72 (55.4) | 99 (77.3) | 79 (61.7) | .365 |
| Anemia | 129 (99.2) | 29 (22.3) | 127 (99.2) | 30 (23.4) | .946 |
| Thrombocytopenia | 66 (50.8) | 23 (17.7) | 79 (61.7) | 28 (21.9) | .492 |
| Febrile neutropenia | 23 (17.7) | 30 (23.4) | .323 | ||
| Nonhematologic toxicity | |||||
| Creatinine elevation | 6 (4.6) | 0 (0.0) | 12 (9.4) | 0 (0.0) | .209† |
| AST elevation | 44 (33.8) | 2 (1.5) | 79 (61.7) | 8 (6.2) | .101 |
| ALT elevation | 48 (36.9) | 2 (1.5) | 87 (68.0) | 10 (7.8) | .036 |
| Bilirubin elevation | 5 (3.8) | 1 (0.8) | 11 (8.6) | 3 (2.3) | .603 |
| Oral mucositis | 43 (33.1) | 8 (6.2) | 69 (53.9) | 19 (14.8) | .038 |
| Interruption of R-CHOP‡ | |||||
| Delay or dose reduction | 22 (16.9) | 40 (31.2) | |||
| Discontinuation | 13 (10.0) | 5 (3.9) | |||
| Event . | Non-ITT HD-MTX (N = 130) . | ITT HD-MTX (N = 128) . | P* . | ||
|---|---|---|---|---|---|
| Any grade . | Grade 3 or 4 . | Any grade . | Grade 3 or 4 . | ||
| Hematologic toxicity | |||||
| Leukopenia | 85 (65.4) | 63 (48.5) | 89 (69.5) | 71 (55.5) | .316 |
| Neutropenia | 89 (68.5) | 72 (55.4) | 99 (77.3) | 79 (61.7) | .365 |
| Anemia | 129 (99.2) | 29 (22.3) | 127 (99.2) | 30 (23.4) | .946 |
| Thrombocytopenia | 66 (50.8) | 23 (17.7) | 79 (61.7) | 28 (21.9) | .492 |
| Febrile neutropenia | 23 (17.7) | 30 (23.4) | .323 | ||
| Nonhematologic toxicity | |||||
| Creatinine elevation | 6 (4.6) | 0 (0.0) | 12 (9.4) | 0 (0.0) | .209† |
| AST elevation | 44 (33.8) | 2 (1.5) | 79 (61.7) | 8 (6.2) | .101 |
| ALT elevation | 48 (36.9) | 2 (1.5) | 87 (68.0) | 10 (7.8) | .036 |
| Bilirubin elevation | 5 (3.8) | 1 (0.8) | 11 (8.6) | 3 (2.3) | .603 |
| Oral mucositis | 43 (33.1) | 8 (6.2) | 69 (53.9) | 19 (14.8) | .038 |
| Interruption of R-CHOP‡ | |||||
| Delay or dose reduction | 22 (16.9) | 40 (31.2) | |||
| Discontinuation | 13 (10.0) | 5 (3.9) | |||