Table 2 |
|||
|
Results of Efficacy Endpoints |
|||
|
Treatment group |
XM02 |
Neupogen™ |
Placebo/XM02* |
|
Full analysis set [n] |
(n = 140) |
(n = 136) |
72 |
|
|
|||
|
Mean DSN [days] |
|||
|
Cycle 1 |
1.1 |
1.1 |
3.8 |
|
ANCOVA [CI]# |
0.028 [-0.261, 0.316] |
||
|
Cycle 4 |
0.7 |
0.7 |
0.6 |
|
|
|||
|
Mean ANC nadir [109/L] |
|||
|
Cycle 1 |
0.7 |
0.7 |
0.2 |
|
ANCOVA [CI]# |
-0.001 [-0.190, 0.189] |
||
|
Cycle 4 |
1.0 |
1.0 |
1.1 |
|
|
|||
|
Mean time to ANC recovery [days] |
|||
|
Cycle 1 |
8.0 |
7.8 |
14.0 |
|
ANCOVA [CI]# |
0.207 [-0.425, 0.838] |
||
|
Cycle 4 |
7.6 |
7.1 |
7.2 |
|
|
|||
|
Incidence of FN [%]+ |
|||
|
Cycle 1 |
12.1 |
12.5 |
36.1 |
|
Across all cycles |
20.7 |
22.1 |
41.7 |
|
|
|||
|
Abbreviations: DSN: duration of severe neutropenia; ANC: absolute neutrophil count; FN: febrile neutropenia; ANCOVA: analysis of covariance, CI: confidence interval. * Patients in this group received placebo in cycle 1 and XM02 afterwards (including in cycle 4). # ANCOVA estimate and 2-sided 95% confidence interval for difference XM02 – Filgrastim in cycle 1. + Observed or protocol defined FN. |
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|
del Giglio et al. BMC Cancer 2008 8:332 doi:10.1186/1471-2407-8-332 |
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