Table 2.
Subject demographics in subjects who received BAX 855
| Parameter | Phase 1 study* (N = 19) | Pivotal study prophylaxis (N = 120) | Pivotal study on-demand (N = 17) | Pivotal study all (N = 137) |
|---|---|---|---|---|
| Median age (minimum-maximum), y | 29 (18-60) | 28 (12-58) | 32 (13-56) | 29 (12-58) |
| Median weight (minimum-maximum), kg | 82.6 (52.5-128.0) | 73.0 (39.5-137.5) | 77.0 (48.0-91.0) | 73.0 (39.5-137.5) |
| Race, n (%) | ||||
| White | 16 (84.2) | 92 (76.7) | 11 (64.7) | 103 (75.2) |
| Asian | 2 (10.5) | 27 (22.5) | 6 (35.3) | 33 (24.1) |
| Black/African American | 0 (0.0) | 1 (0.8) | 0 (0.0) | 1 (0.7) |
| Presence of target joints, n (%) | NA | 78 (65.0) | 15 (88.2) | 93 (67.9) |
| Presence of hemophilic arthropathy, n (%) | NA | 72 (60.0) | 8 (47.1) | 80 (58.4) |
| Hepatitis C virus antibody positive, n (%) | NA | 64 (53.3) | 12 (70.6) | 76 (55.5) |
Two subjects participated in both studies.
N, number of subjects; NA, not applicable (data not collected).
*
Data generated from 2 Japanese subjects in the phase 1 study are not included in the report. An analysis of the 1-stage clotting assay results for these subjects revealed a number of outliers and therefore were not considered in the overall interpretation of PK data for BAX 855 and Advate.