| Primary | Percent Change in Total Bleed Episodes Per Month - Bleeding Population | Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
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| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
| | | Title | Denominators | Categories |
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| Primary | Percent Change in Total Bleed Episodes Per Month - Frequent Bleeding Population | Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month Per Age Categories - Bleeding Population | Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month Per Age Categories - Frequent Bleeding Population | Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Infrequent Dosing | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults. | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Dosing Three Times Per Week | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults. | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Daily Dosing | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults. | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Frequent Dosing | Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults. | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Infrequent Dosing | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Dosing Three Times Per Week | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Daily Dosing | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Primary | Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Frequent Dosing | Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Individual Dose by Dose Regimen and Age Group - Bleeding Population, Paediatric | Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week). | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Median | Full Range | mcg/kg | | Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adolescent | Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week). | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Median | Full Range | mcg/kg | | Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adult | Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week). | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Median | Full Range | mcg/kg | | Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Paediatric | Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week). | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Median | Full Range | mcg/kg | | Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adolescent | Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week). | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Median | Full Range | mcg/kg | | Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adult | Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week). | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Median | Full Range | mcg/kg | | Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Bleeding Population | Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (defined as 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints. | Bleeding population with at least one bleed in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected. Bleed episodes with no recorded locations were not included in the analysis | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Frequent Bleeding Population | Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (= 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected in these patients. Bleed episodes with no recorded locations were not included in the analysis | Posted | | Number | | percent change (%) in bleeds per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Healthcare Resource Consumption of Visits, Consultations, and Hospital Admissions Per Month - All Patients | Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis to the prophylaxis period. | Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days | Posted | | Mean | Standard Deviation | change in events per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Bleeding Population | Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period. | Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months | Posted | | Mean | Standard Deviation | change in events per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Frequent Bleeding Population | Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months | Posted | | Mean | Standard Deviation | change in events per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - All Patients | Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period. | Whole population of all male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (RFVIIa) for at least 30 days. | Posted | | Mean | Standard Deviation | change in days per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
| |
| Secondary | Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Bleeding Population | Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period. | Bleeding population with at least one bleed in the pre-prophylaxis of approximately 6 months. | Posted | | Mean | Standard Deviation | change in days per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
| |
| Secondary | Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Frequent Bleeding Population | Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period. | Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months. | Posted | | Mean | Standard Deviation | change in days per month | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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| Secondary | Physician Reported Outcome Assessment in Prophylaxis in Number of Patients | Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine | Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days | Posted | | Number | | patients | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
| |
| Secondary | Number of Physician Reported Outcome Assessment in Prophylaxis in Percentage of Patients | Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine | Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days | Posted | | Number | | percentage of patients | | Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days. | | | | ID | Title | Description |
|---|
| OG000 | Activated Recombinant Human Factor VII | Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits. |
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