Adverse Events in Tacrolimus and Cyclosporine Groups
| Adverse Events . | Tacrolimus N = 165 (%) . | Cyclosporine N = 164 (%) . | P Value . |
|---|---|---|---|
| Incidence of serum creatinine >2 mg/dL | |||
| Within 8 wk posttransplant | 99 (60) | 79 (48) | .03 |
| Within 26 wk posttransplant | 111 (67) | 98 (60) | .16 |
| Incidence of serum creatinine 2× baseline | |||
| Within 8 wk posttransplant | 132 (80) | 119 (73) | .11 |
| Within 26 wk posttransplant | 139 (84) | 131 (80) | .30 |
| Incidence of hemodialysis | |||
| Within 8 wk posttransplant | 31 (19) | 13 (8) | .004 |
| Within 26 wk posttransplant | 32 (19) | 16 (10) | .01 |
| Nonadvanced disease | 13/97 (13) | 13/116 (11) | .63 |
| Advanced disease | 19/68 (28) | 3/48 (6) | .003 |
| Incidence of veno-occlusive disease | |||
| Within 20 d posttransplant | 44 (27) | 37 (23) | .39 |
| Hyperglycemia requiring insulin5-150 | |||
| At 8 wk | 17 (10) | 7 (4) | .06 |
| At 26 wk | 1 (0.6) | 0 (0) | 1.0 |
| Hypertension requiring treatment while on study drug at 26 wk | 34 (21) | 66 (40) | .001 |
| Adverse Events . | Tacrolimus N = 165 (%) . | Cyclosporine N = 164 (%) . | P Value . |
|---|---|---|---|
| Incidence of serum creatinine >2 mg/dL | |||
| Within 8 wk posttransplant | 99 (60) | 79 (48) | .03 |
| Within 26 wk posttransplant | 111 (67) | 98 (60) | .16 |
| Incidence of serum creatinine 2× baseline | |||
| Within 8 wk posttransplant | 132 (80) | 119 (73) | .11 |
| Within 26 wk posttransplant | 139 (84) | 131 (80) | .30 |
| Incidence of hemodialysis | |||
| Within 8 wk posttransplant | 31 (19) | 13 (8) | .004 |
| Within 26 wk posttransplant | 32 (19) | 16 (10) | .01 |
| Nonadvanced disease | 13/97 (13) | 13/116 (11) | .63 |
| Advanced disease | 19/68 (28) | 3/48 (6) | .003 |
| Incidence of veno-occlusive disease | |||
| Within 20 d posttransplant | 44 (27) | 37 (23) | .39 |
| Hyperglycemia requiring insulin5-150 | |||
| At 8 wk | 17 (10) | 7 (4) | .06 |
| At 26 wk | 1 (0.6) | 0 (0) | 1.0 |
| Hypertension requiring treatment while on study drug at 26 wk | 34 (21) | 66 (40) | .001 |
Patient population: all randomized patients who received a marrow transplant and at least one dose of study drug (tacrolimus group = 165 patients; cyclosporine group = 164 patients).
Patients without history of diabetes mellitus (tacrolimus group = 163 patients; cyclosporine group = 160 patients).