Table 4.

Factors influencing the bleeding rate in weeks 1 to 12

ParameterUnivariate IRR (95% CI)PMultivariate IRR (95% CI)P
FVIII activity category     
 <1% 7.4 (3.1-18) <.0001 7.1 (3.1-16) <.0001 
 1 to <5% 7.5 (3.3-17) <.0001 8.2 (3.7-18) <.0001 
 5 to <20% 6.4 (2.9-14) <.0001 6.5 (3.0-14) <.0001 
 20 to <50% 4.4 (2.0-9.6) .0002 4.6 (2.1-10) <.0001 
 ≥50%   
Age (per year) 1.01 (0.99-1.02) .537   
Body weight (per kg) 1.02 (1.00-1.03) .054   
Female sex 0.90 (0.55-1.5) .682   
WHO performance status     
 0 (best) 0.32 (0.12-0.89) .029 0.23 (0.09-0.62) .004 
 1 0.86 (0.42-1.8) .691 0.61 (0.31-1.2) .151 
 2 0.91 (0.42-1.9) .805 0.63 (0.31-1.3) .211 
 3 1.3 (0.65-2.8) .426 0.81 (0.41-1.6) .552 
 4 or 5 (worst)   
Underlying disorders     
 Malignancy 0.47 (0.19-1.1) .095 
 Autoimmunity 1.0 (0.55-1.8) .986 
 Pregnancy 0.90 (0.29-2.8) .853 
Other baseline conditions     
 Coronary artery disease 1.2 (0.68-2.0) .568   
 Heart failure 1.5 (0.89-2.5) .129   
 Renal insufficiency 1.7 (1.1-2.8) .026 1.4 (0.86-2.1) .185 
 Diabetes mellitus 2.9 (1.2-3.3) .007 1.4 (0.85-2.2) .195 
 Arterial hypertension 0.84 (0.51-1.4) .501   
Time (per week) 0.73 (0.68-0.79) <.0001 0.86 (0.79-0.94) .0015 
ParameterUnivariate IRR (95% CI)PMultivariate IRR (95% CI)P
FVIII activity category     
 <1% 7.4 (3.1-18) <.0001 7.1 (3.1-16) <.0001 
 1 to <5% 7.5 (3.3-17) <.0001 8.2 (3.7-18) <.0001 
 5 to <20% 6.4 (2.9-14) <.0001 6.5 (3.0-14) <.0001 
 20 to <50% 4.4 (2.0-9.6) .0002 4.6 (2.1-10) <.0001 
 ≥50%   
Age (per year) 1.01 (0.99-1.02) .537   
Body weight (per kg) 1.02 (1.00-1.03) .054   
Female sex 0.90 (0.55-1.5) .682   
WHO performance status     
 0 (best) 0.32 (0.12-0.89) .029 0.23 (0.09-0.62) .004 
 1 0.86 (0.42-1.8) .691 0.61 (0.31-1.2) .151 
 2 0.91 (0.42-1.9) .805 0.63 (0.31-1.3) .211 
 3 1.3 (0.65-2.8) .426 0.81 (0.41-1.6) .552 
 4 or 5 (worst)   
Underlying disorders     
 Malignancy 0.47 (0.19-1.1) .095 
 Autoimmunity 1.0 (0.55-1.8) .986 
 Pregnancy 0.90 (0.29-2.8) .853 
Other baseline conditions     
 Coronary artery disease 1.2 (0.68-2.0) .568   
 Heart failure 1.5 (0.89-2.5) .129   
 Renal insufficiency 1.7 (1.1-2.8) .026 1.4 (0.86-2.1) .185 
 Diabetes mellitus 2.9 (1.2-3.3) .007 1.4 (0.85-2.2) .195 
 Arterial hypertension 0.84 (0.51-1.4) .501   
Time (per week) 0.73 (0.68-0.79) <.0001 0.86 (0.79-0.94) .0015 

Incidence rate ratios (IRRs) corresponding to exp(B) from generalized linear mixed model of weekly bleeding rate (dependent variable, utilizing negative binomial distribution, and log link function) with indicated parameters. Age, body weight, and time were entered as continuous factors. All other parameters were entered as categorical factors as indicated. Univariate IRRs were corrected for time. Multivariate IRRs were corrected for time and the parameters achieving a significance level of P < .05 in univariate analyses.

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