Study Protocol Performance
| . | Ciprofloxacin + Metronidazole . | Ciprofloxacin . | Total . |
|---|---|---|---|
| Treatment according to protocol* | 60 (88) | 60 (91) | 120 (90) |
| Protocol violations* | |||
| GVHD prophylaxis† | 2 (3) | 1 (2) | 3 (2) |
| Premature cyclosporine withdrawal | 1 (2) | — | 1 (1) |
| Drop-outs* | |||
| Early death‡ | 3 (4) | 1 (1) | 4 (3) |
| Primary graft failure‡ | 1 (2) | 3 (5) | 4 (3) |
| Early relapse‡ | 1 (2) | 1 (1) | 2 (2) |
| Total* | 68 (100) | 66 (100) | 134 (100) |
| . | Ciprofloxacin + Metronidazole . | Ciprofloxacin . | Total . |
|---|---|---|---|
| Treatment according to protocol* | 60 (88) | 60 (91) | 120 (90) |
| Protocol violations* | |||
| GVHD prophylaxis† | 2 (3) | 1 (2) | 3 (2) |
| Premature cyclosporine withdrawal | 1 (2) | — | 1 (1) |
| Drop-outs* | |||
| Early death‡ | 3 (4) | 1 (1) | 4 (3) |
| Primary graft failure‡ | 1 (2) | 3 (5) | 4 (3) |
| Early relapse‡ | 1 (2) | 1 (1) | 2 (2) |
| Total* | 68 (100) | 66 (100) | 134 (100) |
No. of patients (rounded percentage of patients) in each study arm.
Two patients stratified to short methotrexate + cyclosporine received cyclosporine only; one patient stratified to cyclosporine received short methotrexate + cyclosporine.
Early death: patients deceased without marrow function before day 30 posttransplant. Primary graft failure: patients with documented graft failure at day 30 posttransplant. Early relapse: patients with disease recurrence within 30 days posttransplant.