| Primary | Number of Participants Who Discontinued the Use of Study Drug | Number of previously treated patients (PTPs) and previously untreated patients (PUPs) who discontinued the use of ADYNOVATE were reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | | Count of Participants | | Participants | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Annual Bleed Rate (ABR) of Spontaneous Bleeding Episodes on a Prophylaxis Regimen | Annual bleed rate (ABR) of spontaneous bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced spontaneous bleeding episodes during the administration period. | Posted | | Median | Inter-Quartile Range | Bleeds per year | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Annual Bleed Rate (ABR) of Breakthrough Bleeding Episodes on a Prophylaxis Regimen | Annual bleed rate (ABR) of breakthrough bleeding episodes in PTPs and PUPs on a prophylaxis regimen were reported. Annual bleed rate is calculated by the number of bleeding episodes observed during administration period divided by the duration of administration period, after that multiplied with 365.2425. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period. | Posted | | Median | Inter-Quartile Range | Bleeds per year | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Duration of Treatment of Study Drug on a Prophylaxis Regimen | Duration of treatment of study drug on a prophylaxis regimen was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | Posted | | Mean | Standard Deviation | days | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs. | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Duration of Treatment of Study Drug an On-Demand Regimen | Duration of treatment of study drug on an on-demand regimen was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | Posted | | Mean | Standard Deviation | days | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Dose Per Administration of Study Drug on a Prophylaxis Regimen | Dose per administration of study drug on a prophylaxis regimen was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | Posted | | Mean | Standard Deviation | IU per kilograms (kg) | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Dose Per Administration of Study Drug an On-Demand Regimen | Dose per administration of study drug on an on-demand regimen was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | Posted | | Mean | Standard Deviation | IU per kilograms (kg) | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Secondary | Number of Doses Per a Week of Study Drug on a Prophylaxis Regimen | Number of doses per a week of study drug on a prophylaxis regimen was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen during the administration period. | Posted | | Mean | Standard Deviation | Number of doses per a week | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Number of Doses Per a Bleeding Episode of Study Drug an On-Demand Regimen | Number of doses per a bleeding episode of study drug on an on-demand regimen was reported. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with an on-demand regimen during the administration period. | Posted | | Mean | Standard Deviation | Number of doses per a bleeding episode | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Count of Bleeding Episodes | Count of Bleeding Episodes | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Hemostatic Effectiveness of Study Drug on Treatment of Breakthrough Bleeding Episodes With a Prophylaxis Regimen | Percentage of each category of hemostatic effectiveness for treatment of breakthrough bleeding episodes in a prophylaxis regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor. | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis who treated with a prophylaxis regimen and experienced breakthrough bleeding episodes during the administration period. | Posted | | Number | | Percentage of bleeding episodes | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Count of Bleeding Episodes | Count of Bleeding Episodes | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Primary | Hemostatic Effectiveness of Study Drug on an On-Demand Regimen | Percentage of each category of hemostatic effectiveness for an on-demand regimen assessed by the investigator was reported. Hemostatic effectiveness was assessed by the investigator with following 4-point ordinal scale: Excellent, Good, Fair, Poor. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. The number analyzed was the number of participants with data available for analysis who treated with on-demand regimen during the administration period. | Posted | | Number | | Percentage of bleeding episodes | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | Count of Bleeding Episodes | Count of Bleeding Episodes | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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| Secondary | Number of Participants Who Experience Factor VIII Inhibition, Dermatitis Atopic or Eczema as an Adverse Event (AE) | Number of PTPs and PUPs who experienced factor VIII inhibition, dermatitis atopic or eczema as an AE related to development of inhibitors, shock or anaphylaxis was reported. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | | Count of Participants | | Participants | | Throughout the study participation period: 1 year for previously treated patients for PTPs and 2 years for previously untreated patients for PUPs | | | | ID | Title | Description |
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| OG000 | Previously Treated Patients (PTPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously treated patients with Factor VIII deficiency (PTPs) who had 4 or more exposure days to other Factor VIII (FVIII) products. | | OG001 | Previously Untreated Patients (PUPs) | Participants with hemophilia A who received Recombinant Factor VIII (FVIII) PEGylated (ADYNOVATE) intravenous Infusion as part of a routine medical care. Participants in this group were previously untreated patients with Factor VIII deficiency (PUPs) who had 3 or less previous exposure days to other Factor VIII (FVIII) products. |
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