| Primary | Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None | Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as "last stitch"). Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 49 surgeries were evaluated in 35 participants. | Posted | | Number | | Surgeries | | Assessed by the Investigator/surgeon at the day of surgery | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
| | Units | Counts |
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| Participants | | | Surgeries | |
| | Title | Denominators | Categories |
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| Excellent | | | | Good | | | | Moderate | | |
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| Secondary | Average Consumption of N8-GP During Surgery | Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. N8-GP was administered during 1 surgery for 1 participant. | Posted | | Number | | IU/kg | | During surgery, defined as the time from "knife to skin" until "last stitch" | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6 | Haemostatic effect during post-operative period days 1-6 as evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 2 surgeries with 2 bleeding episodes were evaluated in 35 participants. | Posted | | Number | | bleeding episodes | | During the post-operative period, days 1-6 | bleeding episodes | bleeding episodes | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14 | Haemostatic effect during post-operative period days 1-6 and days 7-14 was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 2 surgeries with 2 bleeding episodes were evaluated in 35 participants. | Posted | | Number | | bleeding episodes | | During the post-operative period, days 7-14 | bleeding episodes | bleeding episodes | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Average Consumption of N8-GP During the Post-operative Period Days 1-6 | Average consumption of N8-GP during post operative period days 1-6 is presented. Analysis population: Full analysis set included all subjects exposed to the trial drug (N8-GP) and completed surgery. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 49 surgeries were evaluated in 35 participants. | Posted | | Mean | Standard Deviation | IU/kg | | During the post-operative period, days 1-6 | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL) | Incidence rate of inhibitors is the number of newly developed inhibitors per surgery. Development of FVIII inhibitors was measured by a validated Nijmegen modified Bethesda assay. A positive inhibitor test was defined as ≥0.6 bethesda unit. Number of participants with inhibitors at the end of trial is presented. | Safety analysis set (SAS) included all patients exposed to trial drug (N8-GP). | Posted | | Number | | Participants | | during the trial (2-5 weeks) | | | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Estimated Blood Loss During Surgery | The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 49 surgeries were evaluated in 35 participants. | Posted | | Mean | Standard Deviation | mL | | During surgery | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Number of Transfusions During the Post-operative Period Days 1-6 | Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. | Posted | | Number | | blood transfusions | | Post-operative period, days 1-6 | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Length of Stay in the Hospital | Mean number of days stayed at the hospital during the trial. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. | Posted | | Mean | Standard Deviation | days | | During the trial (2-5 weeks) | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Number of Days in Intensive Care | Mean number of days in the intensive care due to surgery during the trial is presented. | Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. | Posted | | Mean | Standard Deviation | days | | During the trial (2-5 weeks) | Surgeries | Surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Adverse Events Reported During the Trial Period | Number of adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14). | Safety analysis set (SAS) included all patients exposed to trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. | Posted | | Number | | adverse events | | During the trial (2-5 weeks) | Planned surgeries | Planned surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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| Secondary | Serious Adverse Events Reported During the Trial Period | Number of serious adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14). | Safety analysis set (SAS) included all patients exposed to trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. | Posted | | Number | | serious adverse event | | During the trial (2-5 weeks) | planned surgeries | planned surgeries | | ID | Title | Description |
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| OG000 | NNC 0129-0000-1003 (Turoctocog Alfa Pegol) | Subjects (from trial NN7088-3859) undergoing major surgery received bleeding preventive treatment with turoctocog alfa pegol (N8-GP) before, during and after surgery. The trial product was administered as a slow bolus intravenous injection. Dosing was done at the investigators' discretion (except a fixed dose of 50 IU/kg at screening visit). The dose level of N8-GP during this trial was chosen following the coagulation factor 8 (FVIII) activity levels recommended by World Federation of Hemophilia (WFH) guidelines. The WFH guidelines for desired FVIII levels in major surgery are as follows: pre-surgery (day 0): 80-100%; post-surgery days 1-3: 60-80%; days 4-6: 40-60%; days 7-14: 30-50%. All subjects were treated with doses between 20-75 IU/kg for treatment of a bleeding episode. The maximum dose to be administered to a subject within 24 hours was 200 IU/kg. The total duration of the trial was 2-5 weeks. Upon completion of this trial, subjects returned to trial NN7088-3859. |
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