Summary of risk factors by inhibitor subgroup in the safety analysis set
| Factor . | Inhibitor (n = 28), n (%) . | Noninhibitor (n = 75), n (%) . |
|---|---|---|
| Race | ||
| Black or White Hispanic (n = 14) | 5 (35.7) | 9 (64.3) |
| Other (n = 89) | 23 (25.8) | 66 (74.2) |
| Family history of inhibitor | ||
| Yes (n = 20) | 9 (45.0) | 11 (55.0) |
| No (n = 71) | 15 (21.1) | 56 (78.9) |
| Unknown (n = 12) | 4 (33.3) | 8 (66.7) |
| Genotype | ||
| High risk (n = 82) | 23 (28.0) | 59 (72.0) |
| Low risk (n = 5) | 1 (20.0) | 4 (80.0) |
| Unknown risk (n = 16) | 4 (25.0) | 12 (75.0) |
| TEAE of infection | ||
| Yes (n = 75) | 17 (22.7) | 58 (77.3) |
| No (n = 28) | 11 (39.3) | 17 (60.7) |
| Factor . | Inhibitor (n = 28), n (%) . | Noninhibitor (n = 75), n (%) . |
|---|---|---|
| Race | ||
| Black or White Hispanic (n = 14) | 5 (35.7) | 9 (64.3) |
| Other (n = 89) | 23 (25.8) | 66 (74.2) |
| Family history of inhibitor | ||
| Yes (n = 20) | 9 (45.0) | 11 (55.0) |
| No (n = 71) | 15 (21.1) | 56 (78.9) |
| Unknown (n = 12) | 4 (33.3) | 8 (66.7) |
| Genotype | ||
| High risk (n = 82) | 23 (28.0) | 59 (72.0) |
| Low risk (n = 5) | 1 (20.0) | 4 (80.0) |
| Unknown risk (n = 16) | 4 (25.0) | 12 (75.0) |
| TEAE of infection | ||
| Yes (n = 75) | 17 (22.7) | 58 (77.3) |
| No (n = 28) | 11 (39.3) | 17 (60.7) |
Safety analysis set (n = 103). Percentages are based on the number of subjects at each level of the risk factor. Subjects developing a positive inhibitor (≥0.6 BU/mL, confirmed by a second test result from a separate sample drawn ≥2 wk after the date of the original sample) after exposure to rFVIIIFc are included in the inhibitor subgroup. Not all patients may have had an inhibitor test and were thus considered noninhibitor subjects.