Table 2.
Non-hematologic toxicity
| Adverse Event | All Patients (N=202) |
Busulfan+Melphalan (N=104) |
Melphalan (N=98) |
p-value |
|---|---|---|---|---|
| Overall | ||||
| None | 0 | 0 | 0 | <0.0001 |
| Grade 1 | 17 (8%) | 1 (1%) | 16 (16%) | |
| Grade 2 | 66 (33%) | 16 (15%) | 50 (51%) | |
| Grade 3 | 118 (58%) | 86 (83%) | 32 (33%) | |
| Grade 4 | 1 (0.5%) | 1 (1%) | 0 | |
| Diarrhea | ||||
| None | 67 (33%) | 45 (43%) | 22 (22%) | 0.056 |
| Grade 1 | 107 (53%) | 44 (42%) | 63 (64%) | |
| Grade 2 | 21 (10%) | 11 (11%) | 10 (10%) | |
| Grade 3 | 7 (3%) | 4 (4%) | 3 (3%) | |
| Mucositis | ||||
| None | 54 (27%) | 4 (4%) | 50 (51%) | <0.0001 |
| Grade 1 | 57 (28%) | 23 (22%) | 34 (35%) | |
| Grade 2 | 76 (38%) | 62 (60%) | 14 (14%) | |
| Grade 3 | 15 (7%) | 15 (14%) | 0 | |
| Nausea | ||||
| None | 9 (4%) | 7 (7%) | 2 (2%) | 0.91 |
| Grade 1 | 51 (25%) | 22 (21%) | 29 (30%) | |
| Grade 2 | 136 (67%) | 71 (68%) | 65 (66%) | |
| Grade 3 | 6 (3%) | 4 (4%) | 2 (2%) | |
| ALT | ||||
| None | 167 (83%) | 70 (67%) | 97 (99%) | <0.0001 |
| Grade 1 | 25 (12%) | 24 (23%) | 1 (1%) | |
| Grade 2 | 7 (3%) | 7 (7%) | 0 | |
| Grade 3 | 3 (1%) | 3 (3%) | 0 | |
| AST | ||||
| None | 200 (99%) | 103 (99%) | 97 (99%) | 1.00 |
| Grade 1 | 1 (0.5%) | 0 | 1 (1%) | |
| Grade 2 | 1 (0.5%) | 1 (1%) | 0 | |
| Grade 3 | 0 | 0 | 0 | |
| Bilirubin | ||||
| None | 182 (90%) | 94 (90%) | 88 (90%) | 1.00 |
| Grade 1 | 9 (4%) | 5 (5%) | 4 (4%) | |
| Grade 2 | 9 (4%) | 3 (3%) | 6 (6%) | |
| Grade 3 | 2 (1%) | 2 (2%) | 0 | |
| Neutropenic fever | ||||
| None | 99 (49%) | 30 (29%) | 69 (70%) | <0.0001 |
| Grade 1 | 1 (0.5%) | 1 (1%) | 0 | |
| Grade 2 | 0 | 0 | 0 | |
| Grade 3 | 102 (51%) | 73 (70%) | 29 (30%) |
Data are n (%%)
ALT, alanine aminotransferase; AST, aspartate aminotransferase