CoxPH ratio analysis of inhibitor risk in participants with severe HA who had either 50 EDs or confirmed inhibitor
| Variable . | Univariate with no adjustment . | With adjustment∗ . | ||||
|---|---|---|---|---|---|---|
| HR . | 95% CI . | P value . | HR . | 95% CI . | P value . | |
| Ethnicity,not Hispanic, Latino, or Spanish origin (reference) | ||||||
| Hispanic, Latino, or Spanish origin | 0.72 | 0.30-1.72 | .460 | 0.89 | 0.27-2.91 | .844 |
| Race, White (reference) | ||||||
| Asian | 0.70 | 0.10-5.17 | .729 | 0.27 | 0.02-4.27 | .351 |
| Black or African American | 1.50 | 0.68-3.31 | .312 | 1.31 | 0.30-5.70 | .721 |
| Others | 0.68 | 0.21-2.24 | .526 | 0.73 | 0.16-3.39 | .690 |
| Variant type (for participants with genotyping), missense and splice site change (reference) | ||||||
| Frameshift | 5.98 | 0.67-53.52 | .110 | 3.86 | 0.39-38.60 | .250 |
| Inversion intron 22 | 7.59 | 0.96-59.96 | .054 | 7.23 | 0.85-61.45 | .070 |
| Large structural change of >50 base pair | 16.59 | 1.94-142.20 | .010 | 14.50 | 1.54-136.92 | .020 |
| Nonsense | 12.47 | 1.53-101.36 | .018 | 12.53 | 1.41-111.49 | .023 |
| Age at first product exposure,† 1-12 mo (reference) | ||||||
| <1 mo | 2.57 | 1.22-5.44 | .013 | 2.27 | 0.89-5.82 | .087 |
| 1-10 y | 2.01 | 0.79-5.10 | .143 | 3.41 | 0.96-12.08 | .057 |
| First product exposure† given for ≥5 days, no (reference) | ||||||
| Yes | 1.22 | 0.50-2.96 | .655 | 1.20 | 0.21-6.93 | .838 |
| Unknown | 1.30 | 0.45-3.71 | .625 | 1.09 | 0.34-3.45 | .885 |
| Variable . | Univariate with no adjustment . | With adjustment∗ . | ||||
|---|---|---|---|---|---|---|
| HR . | 95% CI . | P value . | HR . | 95% CI . | P value . | |
| Ethnicity,not Hispanic, Latino, or Spanish origin (reference) | ||||||
| Hispanic, Latino, or Spanish origin | 0.72 | 0.30-1.72 | .460 | 0.89 | 0.27-2.91 | .844 |
| Race, White (reference) | ||||||
| Asian | 0.70 | 0.10-5.17 | .729 | 0.27 | 0.02-4.27 | .351 |
| Black or African American | 1.50 | 0.68-3.31 | .312 | 1.31 | 0.30-5.70 | .721 |
| Others | 0.68 | 0.21-2.24 | .526 | 0.73 | 0.16-3.39 | .690 |
| Variant type (for participants with genotyping), missense and splice site change (reference) | ||||||
| Frameshift | 5.98 | 0.67-53.52 | .110 | 3.86 | 0.39-38.60 | .250 |
| Inversion intron 22 | 7.59 | 0.96-59.96 | .054 | 7.23 | 0.85-61.45 | .070 |
| Large structural change of >50 base pair | 16.59 | 1.94-142.20 | .010 | 14.50 | 1.54-136.92 | .020 |
| Nonsense | 12.47 | 1.53-101.36 | .018 | 12.53 | 1.41-111.49 | .023 |
| Age at first product exposure,† 1-12 mo (reference) | ||||||
| <1 mo | 2.57 | 1.22-5.44 | .013 | 2.27 | 0.89-5.82 | .087 |
| 1-10 y | 2.01 | 0.79-5.10 | .143 | 3.41 | 0.96-12.08 | .057 |
| First product exposure† given for ≥5 days, no (reference) | ||||||
| Yes | 1.22 | 0.50-2.96 | .655 | 1.20 | 0.21-6.93 | .838 |
| Unknown | 1.30 | 0.45-3.71 | .625 | 1.09 | 0.34-3.45 | .885 |
Results with adjustment are from multivariable analysis with all 5 variables.
Product classes include factor replacement, activated prothrombin complex concentrate, rFVIIa, FVIII mimetic, blood bank products (cryoprecipitate, fresh frozen plasma, and packed red blood cells), other hemostatic agents, and unknown.