Hemophilia B
Conditions
Keywords
Hemophilia B, observational, post marketing study
Brief summary
The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
Detailed description
No sampling
Interventions
OTHERNo intervention
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX. * Subjects who have dated and signed the informed consent form.
Exclusion criteria
* Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX. * Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment | Baseline up to Year 3.5 | A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An 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; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment | Year 3.5 up to 4.75 | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX. |
| Number of Participants With Events of Special Interest | Baseline up to Year 4.75 | Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Efficacy by Participant | Baseline up to Year 4.75 | Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant. |
| Dose Per Injection of BeneFIX | Baseline up to Year 4.75 | Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category. |
| Number of Bleeding Episodes | Baseline up to Year 4.75 | Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category. |
| Subjective Assessment of Ease of Use by Participant | Baseline up to Year 4.75 | Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant. |
| Subjective Assessment of Efficacy by Physician | Baseline up to Year 4.75 | Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician. |
| Number of Bleeding Episodes Requiring Treatment by Injection | Baseline up to Year 4.75 | Number of injections (1, 2, 3 or greater than or equal to \[\>= 4\]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. |
| Total Consumption of BeneFIX | Baseline up to Year 4.75 | Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BeneFIX (Previously Treated Participants) Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years. | 57 |
| BeneFIX (Previously Untreated Participants) Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years. | 1 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Other | 8 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | BeneFIX (Previously Treated Participants) | BeneFIX (Previously Untreated Participants) | Total |
|---|---|---|---|
| Age, Continuous | 23.36 years STANDARD_DEVIATION 16.237 | 1.30 years | 22.98 years STANDARD_DEVIATION 16.353 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 57 Participants | 1 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 57 | 0 / 1 |
| serious Total, serious adverse events | 10 / 57 | 1 / 1 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.
Time frame: Year 3.5 up to 4.75
Population: Safety population included all participants who received at least one dose of BeneFIX. Previously untreated participants were not evaluable for this outcome measure due to discontinuation prior to safety amendment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment | AE | 26 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment | SAE | 10 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment | Treatment-related AE | 1 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment | Treatment-related SAE | 0 participants |
Primary
Number of Participants With Events of Special Interest
Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.
Time frame: Baseline up to Year 4.75
Population: Safety population included all participants who received at least one dose of BeneFIX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Number of Participants With Events of Special Interest | FIX inhibitor | 0 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Events of Special Interest | RBC agglutination | 0 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Events of Special Interest | Lack of efficacy/ low recovery | 0 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Events of Special Interest | Thrombotic event | 0 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Events of Special Interest | Allergic reactions | 0 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Events of Special Interest | Allergic reactions | 0 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Events of Special Interest | Thrombotic event | 0 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Events of Special Interest | RBC agglutination | 0 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Events of Special Interest | FIX inhibitor | 1 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Events of Special Interest | Lack of efficacy/ low recovery | 0 participants |
Primary
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An 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; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.
Time frame: Baseline up to Year 3.5
Population: Safety population included all participants who received at least one dose of BeneFIX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment | Treatment-related AE | 1 participants |
| BeneFIX (Previously Treated Participants) | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment | Treatment-related SAE | 0 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment | Treatment-related AE | 1 participants |
| BeneFIX (Previously Untreated Participants) | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment | Treatment-related SAE | 1 participants |
Secondary
Dose Per Injection of BeneFIX
Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.
Time frame: Baseline up to Year 4.75
Population: Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Dose Per Injection of BeneFIX | Prophylaxis (n=28) | 45.3 IU/kg | Standard Deviation 11.41 |
| BeneFIX (Previously Treated Participants) | Dose Per Injection of BeneFIX | On demand (n=21) | 49.0 IU/kg | Standard Deviation 14.25 |
Secondary
Number of Bleeding Episodes
Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'n' signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category.
Time frame: Baseline up to Year 4.75
Population: Efficacy population: participants with basal FIX activity less than or equal to (\<=) 1 percent (%) with real exposure days in diary at least 70% of planned exposure days for prophylaxis period, and without FIX inhibitor before or during study (no FIX inhibitor history at baseline; FIX inhibitor titer \<0.6 Bethesda Unit \[BU\] during follow up).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes | Prophylaxis (n=28) | 261 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes | On demand (n=21) | 695 bleeding episodes |
Secondary
Number of Bleeding Episodes Requiring Treatment by Injection
Number of injections (1, 2, 3 or greater than or equal to \[\>= 4\]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.
Time frame: Baseline up to Year 4.75
Population: Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'number of bleeding episodes analyzed' signifies episodes evaluable for this measure. 'n' signifies those bleeding episodes with injection data available during specified period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | Prophylaxis: 1 Injection (n = 261) | 144 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | On demand: 1 Injection (n = 694) | 515 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | Prophylaxis: 2 Injection (n = 261) | 63 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | On demand: 2 Injection (n = 694) | 89 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | Prophylaxis: 3 Injection (n = 261) | 21 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | On demand: 3 Injection (n = 694) | 35 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | Prophylaxis: >=4 Injection (n = 261) | 33 bleeding episodes |
| BeneFIX (Previously Treated Participants) | Number of Bleeding Episodes Requiring Treatment by Injection | On demand: >=4 Injection (n = 694) | 55 bleeding episodes |
Secondary
Subjective Assessment of Ease of Use by Participant
Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.
Time frame: Baseline up to Year 4.75
Population: Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Latest assessment: Missing | 5 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Latest assessment: Very Good | 17 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Latest assessment: Good | 19 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Latest assessment: Moderate | 1 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Latest assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Worst assessment: Missing Value | 5 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Worst assessment: Very Good | 13 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Worst assessment: Good | 22 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Worst assessment: Moderate | 2 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Best assessment: Missing Values | 5 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Best assessment: Very Good | 21 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Best assessment: Good | 16 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Best assessment: Moderate | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Best assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Ease of Use by Participant | Worst assessment: Bad | 0 participants |
Secondary
Subjective Assessment of Efficacy by Participant
Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.
Time frame: Baseline up to Year 4.75
Population: Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Latest assessment: Missing Values | 4 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Latest assessment: Very Good | 19 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Latest assessment: Good | 19 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Latest assessment: Moderate | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Latest assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Worst assessment: Missing Values | 4 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Worst assessment: Very Good | 17 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Worst assessment: Good | 20 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Worst assessment: Moderate | 1 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Worst assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Best assessment: Missing Values | 4 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Best assessment: Moderate | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Best assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Best assessment: Very Good | 25 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Participant | Best assessment: Good | 13 participants |
Secondary
Subjective Assessment of Efficacy by Physician
Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.
Time frame: Baseline up to Year 4.75
Population: Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Latest assessment: Very Good | 17 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Latest assessment: Good | 23 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Latest assessment: Moderate | 2 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Latest assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Worst assessment: Very Good | 10 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Worst assessment: Good | 29 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Worst assessment: Moderate | 3 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Worst assessment: Bad | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Best assessment: Very Good | 31 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Best assessment: Good | 11 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Best assessment: Moderate | 0 participants |
| BeneFIX (Previously Treated Participants) | Subjective Assessment of Efficacy by Physician | Best assessment: Bad | 0 participants |
Secondary
Total Consumption of BeneFIX
Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.
Time frame: Baseline up to Year 4.75
Population: Safety population included all participants who received at least one dose of BeneFIX. Participants with at least one follow-up visit were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BeneFIX (Previously Treated Participants) | Total Consumption of BeneFIX | 434751.0 International Unit (IU) | Standard Deviation 446077.9 |
| BeneFIX (Previously Untreated Participants) | Total Consumption of BeneFIX | 15000.0 International Unit (IU) | — |