Results of Secondary Safety Endpoints
| Endpoint . | CD34Selected Arm (n = 66) . | Unselected Arm (n = 64) . | P Value . |
|---|---|---|---|
| Median (range) | Median (range) | ||
| Days to neutrophil engraftment | 12 (9-15) | 12 (9-14) | .013 |
| Days to platelet engraftment | 11 (1-56) | 9 (1-42) | .003 |
| Days to platelet recovery | 11 (8-119) | 10 (7-42) | .004 |
| Platelet transfusions (events/patient) | 3 (0-26) | 2 (0-24) | .011 |
| RBC transfusions (units/patient) | 4 (0-30) | 4 (0-18) | .208 |
| Days of initial hospitalization | 17 (4-60) | 16 (12-69) | .123 |
| Days of rehospitalization | 0 (0-32) | 0 (0-19) | .849 |
| No. (%) | No. (%) | ||
| Incidence of infections (day 0 to day 100) | 37 (56%) | 36 (56%) | .492 |
| No. of infections/patient (day 0 to day 100) | |||
| 0 Infections | 29 (44%) | 28 (44%) | .702 |
| 1 Infection | 19 (29%) | 22 (34%) | |
| 2 Infections | 12 (18%) | 10 (16%) | |
| 3-5 Infections | 6 (9%) | 4 (6%) | |
| Incidence of bleeding events (day 0 to day 100) | 8/66 (12%) | 3/64 (5%) | .207 |
| Endpoint . | CD34Selected Arm (n = 66) . | Unselected Arm (n = 64) . | P Value . |
|---|---|---|---|
| Median (range) | Median (range) | ||
| Days to neutrophil engraftment | 12 (9-15) | 12 (9-14) | .013 |
| Days to platelet engraftment | 11 (1-56) | 9 (1-42) | .003 |
| Days to platelet recovery | 11 (8-119) | 10 (7-42) | .004 |
| Platelet transfusions (events/patient) | 3 (0-26) | 2 (0-24) | .011 |
| RBC transfusions (units/patient) | 4 (0-30) | 4 (0-18) | .208 |
| Days of initial hospitalization | 17 (4-60) | 16 (12-69) | .123 |
| Days of rehospitalization | 0 (0-32) | 0 (0-19) | .849 |
| No. (%) | No. (%) | ||
| Incidence of infections (day 0 to day 100) | 37 (56%) | 36 (56%) | .492 |
| No. of infections/patient (day 0 to day 100) | |||
| 0 Infections | 29 (44%) | 28 (44%) | .702 |
| 1 Infection | 19 (29%) | 22 (34%) | |
| 2 Infections | 12 (18%) | 10 (16%) | |
| 3-5 Infections | 6 (9%) | 4 (6%) | |
| Incidence of bleeding events (day 0 to day 100) | 8/66 (12%) | 3/64 (5%) | .207 |
A number of secondary safety endpoints were evaluated for between-arm differences. There were statistically significant differences between the arms for four endpoints: times to neutrophil engraftment, platelet engraftment, and platelet recovery and number of platelet transfusion events. There were no statistically significant differences between the treatment arms for any of the other secondary safety endpoints.