Hemophilia B
Conditions
Brief summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
Detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Interventions
DRUGBeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.
Exclusion criteria
* Patients with hemophilia B treated with a product other than BeneFIX®. * Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline until last visit (up to 8.7 years) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious. |
| Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline until last visit (up to 8.7 years) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious. Relatedness to BeneFIX was assessed by the investigator. |
| Number of Participants With Adverse Events (AEs) of Special Interest | Baseline until last visit (up to 8.7 years) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity. |
| Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | Baseline until last visit (up to 8.7 years) | FIX inhibitor development was defined as measured inhibitor titer of greater than (\>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay. |
| Investigator Assessment of Treatment Tolerability of Participants | End of study visit (any time up to 8.7 years) | Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor. |
| Participant Assessment of Treatment Tolerability | End of study visit (any time up to 8.7 years) | Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Treatment Handling by the Participants | End of study visit (any time up to 8.7 years) | Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor. |
| Assessment of Treatment Efficacy by the Participants | End of study visit (any time up to 8.7 years) | Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor. |
| Investigator Assessment of Treatment Satisfaction of Participants | Baseline up to 8.7 years | Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied. |
| Mean Total Number of Bleeding Episodes in Participants | Baseline until last visit (up to 8.7 years) | Participants documented all bleeding episodes in a diary during the study. |
| Mean Total Number of Bleeding Episodes Per Year in Participants | Baseline until last visit (up to 8.7 years) | Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation. |
| Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Baseline, up to 8.7 years | Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported. |
| Investigator Assessment of Treatment Efficacy of Participants | End of study visit (any time up to 8.7 years) | Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor. |
| Investigator Assessment of Treatment Handling of Participants | End of study visit (any time up to 8.7 years) | Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor. |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BeneFIX: On Demand Participants were treated with IV injection of BeneFIX whenever they had a bleeding episode, as a part of routine clinical practice at a dose and frequency prescribed by treating physician (with a mean recommended dose of 42.4 ± 16.6 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study. | 25 |
| BeneFIX: Prophylaxis Participants were treated prophylactically with a regular IV injection of BeneFIX to prevent any bleeding episode at a dose and frequency prescribed by treating physician (with a mean recommended dose of 34.4 ± 19.3 IU/kg). Participants were observed for up to a maximum duration of 8.7 years in this study. | 55 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 0 |
Baseline characteristics
| Characteristic | BeneFIX: On Demand | BeneFIX: Prophylaxis | Total |
|---|---|---|---|
| Age, Continuous | 20.2 years STANDARD_DEVIATION 18.8 | 16.0 years STANDARD_DEVIATION 12.2 | 17.3 years STANDARD_DEVIATION 14.6 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 55 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 25 | 46 / 55 |
| serious Total, serious adverse events | 8 / 25 | 29 / 55 |
Outcome results
Primary
Investigator Assessment of Treatment Tolerability of Participants
Investigator assessed the tolerability of participants and categorized as very good, good, moderate and poor.
Time frame: End of study visit (any time up to 8.7 years)
Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Investigator Assessment of Treatment Tolerability of Participants | Very good | 16 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Tolerability of Participants | Good | 7 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Tolerability of Participants | Moderate | 0 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Tolerability of Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Tolerability of Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Tolerability of Participants | Very good | 35 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Tolerability of Participants | Moderate | 1 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Tolerability of Participants | Good | 18 participants |
Primary
Number of Participants With Adverse Events (AEs) of Special Interest
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Adverse Events of special interest included allergic reactions, less than expected therapeutic effect (LETE) of drug, lack of efficacy/low recovery, erythrocyte agglutination in tube or syringe red blood cell (RBC) agglutination phenomena and thrombogenicity.
Time frame: Baseline until last visit (up to 8.7 years)
Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BeneFIX: On Demand | Number of Participants With Adverse Events (AEs) of Special Interest | 0 participants |
| BeneFIX: Prophylaxis | Number of Participants With Adverse Events (AEs) of Special Interest | 0 participants |
Primary
Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay
FIX inhibitor development was defined as measured inhibitor titer of greater than (\>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.
Time frame: Baseline until last visit (up to 8.7 years)
Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BeneFIX: On Demand | Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | 1 participants |
| BeneFIX: Prophylaxis | Number of Participants With Factor IX (FIX) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay | 3 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 8.7 years) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Time frame: Baseline until last visit (up to 8.7 years)
Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 19 participants |
| BeneFIX: On Demand | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 8 participants |
| BeneFIX: Prophylaxis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 49 participants |
| BeneFIX: Prophylaxis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 29 participants |
Primary
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious. Relatedness to BeneFIX was assessed by the investigator.
Time frame: Baseline until last visit (up to 8.7 years)
Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 2 participants |
| BeneFIX: On Demand | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| BeneFIX: Prophylaxis | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 8 participants |
| BeneFIX: Prophylaxis | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
Primary
Participant Assessment of Treatment Tolerability
Participants evaluated their treatment (BeneFIX) tolerability and rated it in 4 categories as very good, good, moderate and poor.
Time frame: End of study visit (any time up to 8.7 years)
Population: Safety analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Participant Assessment of Treatment Tolerability | Very good | 16 participants |
| BeneFIX: On Demand | Participant Assessment of Treatment Tolerability | Moderate | 0 participants |
| BeneFIX: On Demand | Participant Assessment of Treatment Tolerability | Good | 6 participants |
| BeneFIX: On Demand | Participant Assessment of Treatment Tolerability | Poor | 0 participants |
| BeneFIX: Prophylaxis | Participant Assessment of Treatment Tolerability | Good | 14 participants |
| BeneFIX: Prophylaxis | Participant Assessment of Treatment Tolerability | Very good | 37 participants |
| BeneFIX: Prophylaxis | Participant Assessment of Treatment Tolerability | Poor | 0 participants |
| BeneFIX: Prophylaxis | Participant Assessment of Treatment Tolerability | Moderate | 1 participants |
Secondary
Assessment of Treatment Efficacy by the Participants
Participants evaluated the efficacy of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
Time frame: End of study visit (any time up to 8.7 years)
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Assessment of Treatment Efficacy by the Participants | Very good | 11 participants |
| BeneFIX: On Demand | Assessment of Treatment Efficacy by the Participants | Good | 10 participants |
| BeneFIX: On Demand | Assessment of Treatment Efficacy by the Participants | Moderate | 0 participants |
| BeneFIX: On Demand | Assessment of Treatment Efficacy by the Participants | Poor | 1 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Efficacy by the Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Efficacy by the Participants | Very good | 27 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Efficacy by the Participants | Moderate | 0 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Efficacy by the Participants | Good | 25 participants |
Secondary
Assessment of Treatment Handling by the Participants
Participants evaluated the handling (administration) of BeneFIX and rated it in 4 categories as very good, good, moderate and poor.
Time frame: End of study visit (any time up to 8.7 years)
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Assessment of Treatment Handling by the Participants | Very good | 13 participants |
| BeneFIX: On Demand | Assessment of Treatment Handling by the Participants | Good | 8 participants |
| BeneFIX: On Demand | Assessment of Treatment Handling by the Participants | Moderate | 1 participants |
| BeneFIX: On Demand | Assessment of Treatment Handling by the Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Handling by the Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Handling by the Participants | Very good | 37 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Handling by the Participants | Moderate | 0 participants |
| BeneFIX: Prophylaxis | Assessment of Treatment Handling by the Participants | Good | 15 participants |
Secondary
Investigator Assessment of Treatment Efficacy of Participants
Investigator evaluated the efficacy of BeneFIX in participants and rated it in 4 categories as very good, good, moderate and poor.
Time frame: End of study visit (any time up to 8.7 years)
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Investigator Assessment of Treatment Efficacy of Participants | Very good | 10 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Efficacy of Participants | Good | 11 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Efficacy of Participants | Moderate | 1 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Efficacy of Participants | Poor | 1 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Efficacy of Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Efficacy of Participants | Very good | 24 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Efficacy of Participants | Moderate | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Efficacy of Participants | Good | 30 participants |
Secondary
Investigator Assessment of Treatment Handling of Participants
Investigator evaluated the handling (administration) of BeneFIX by participants and rated it in 4 categories as very good, good, moderate and poor.
Time frame: End of study visit (any time up to 8.7 years)
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Investigator Assessment of Treatment Handling of Participants | Very good | 13 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Handling of Participants | Good | 10 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Handling of Participants | Moderate | 0 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Handling of Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Handling of Participants | Poor | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Handling of Participants | Very good | 34 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Handling of Participants | Moderate | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Handling of Participants | Good | 20 participants |
Secondary
Investigator Assessment of Treatment Satisfaction of Participants
Investigator evaluated the participant's satisfaction of treatment with BeneFIX and rated it in 4 categories as very satisfied, satisfied, unsatisfied and very unsatisfied.
Time frame: Baseline up to 8.7 years
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Investigator Assessment of Treatment Satisfaction of Participants | Very satisfied | 12 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Satisfaction of Participants | Satisfied | 9 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Satisfaction of Participants | Unsatisfied | 1 participants |
| BeneFIX: On Demand | Investigator Assessment of Treatment Satisfaction of Participants | Very unsatisfied | 1 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Satisfaction of Participants | Very unsatisfied | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Satisfaction of Participants | Very satisfied | 27 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Satisfaction of Participants | Unsatisfied | 0 participants |
| BeneFIX: Prophylaxis | Investigator Assessment of Treatment Satisfaction of Participants | Satisfied | 27 participants |
Secondary
Mean Total Number of Bleeding Episodes in Participants
Participants documented all bleeding episodes in a diary during the study.
Time frame: Baseline until last visit (up to 8.7 years)
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BeneFIX: On Demand | Mean Total Number of Bleeding Episodes in Participants | 16.7 bleeding episodes | Standard Deviation 21.2 |
| BeneFIX: Prophylaxis | Mean Total Number of Bleeding Episodes in Participants | 17.6 bleeding episodes | Standard Deviation 23.1 |
Secondary
Mean Total Number of Bleeding Episodes Per Year in Participants
Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated by mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.
Time frame: Baseline until last visit (up to 8.7 years)
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BeneFIX: On Demand | Mean Total Number of Bleeding Episodes Per Year in Participants | 4.7 bleeding episodes per year | Standard Deviation 4.7 |
| BeneFIX: Prophylaxis | Mean Total Number of Bleeding Episodes Per Year in Participants | 4.2 bleeding episodes per year | Standard Deviation 4.3 |
Secondary
Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work
Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement was defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.
Time frame: Baseline, up to 8.7 years
Population: Full analysis set included all participants with informed consent and treated with at least 1 dose of Benefix. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX: On Demand | Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Improved | 4 participants |
| BeneFIX: On Demand | Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Unchanged | 9 participants |
| BeneFIX: On Demand | Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Worsened | 2 participants |
| BeneFIX: Prophylaxis | Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Improved | 7 participants |
| BeneFIX: Prophylaxis | Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Unchanged | 20 participants |
| BeneFIX: Prophylaxis | Number of Participants With Change From Baseline Status in Number of Days Missed From School or Work | Worsened | 7 participants |