Trial Outcomes & Findings for Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A (NCT NCT02137850)
NCT ID: NCT02137850
Last Updated: 2025-12-23
Results Overview
Number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) was reported during the main and extension phase of the trial.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
124 participants
Primary outcome timeframe
From start of the treatment up to 7 years
Results posted on
2025-12-23
Participant Flow
The trial was conducted in 14 countries as follows: Australia (2), Austria (2), Bulgaria (1), Canada (1), Germany (1), Greece (2), Israel (1), Italy (1), Japan (3), Malaysia (3), Spain (2), Taiwan (1), Thailand (3), United States (8).
A total of 81 participants were exposed to Turoctocog alfa pegol (N8-GP). Trial consists of main phase: pre-prophylaxis, prophylaxis \& immune tolerance induction (ITI) and extension phase: prophylaxis period until end of treatment. Pre-prophylaxis was optional and allowed participants to receive treatment until 24 months of age/upon reaching 20EDs, whichever came first. Other participants directly started on prophylaxis treatment at visit 1.
Participant milestones
| Measure |
Pre-prophylaxis
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Main Phase: Pre-Prophylaxis
STARTED
|
55
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
COMPLETED
|
44
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
NOT COMPLETED
|
11
|
0
|
0
|
|
Main Phase: Prophylaxis
STARTED
|
0
|
69
|
0
|
|
Main Phase: Prophylaxis
COMPLETED
|
0
|
55
|
0
|
|
Main Phase: Prophylaxis
NOT COMPLETED
|
0
|
14
|
0
|
|
Immune Tolerance Induction
STARTED
|
0
|
0
|
8
|
|
Immune Tolerance Induction
COMPLETED
|
0
|
0
|
4
|
|
Immune Tolerance Induction
NOT COMPLETED
|
0
|
0
|
4
|
|
Extension Phase: Prophylaxis
STARTED
|
0
|
55
|
0
|
|
Extension Phase: Prophylaxis
COMPLETED
|
0
|
49
|
0
|
|
Extension Phase: Prophylaxis
NOT COMPLETED
|
0
|
6
|
0
|
Reasons for withdrawal
| Measure |
Pre-prophylaxis
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Main Phase: Pre-Prophylaxis
Withdrawal by parent/guardian
|
1
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
Protocol Violation
|
1
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
Adverse Event
|
3
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
Withdrawal by Subject
|
2
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
Lack of Efficacy
|
1
|
0
|
0
|
|
Main Phase: Pre-Prophylaxis
Other
|
3
|
0
|
0
|
|
Main Phase: Prophylaxis
Withdrawal by parent/guardian
|
0
|
2
|
0
|
|
Main Phase: Prophylaxis
Protocol Violation
|
0
|
1
|
0
|
|
Main Phase: Prophylaxis
Adverse Event
|
0
|
4
|
0
|
|
Main Phase: Prophylaxis
Lack of Efficacy
|
0
|
1
|
0
|
|
Main Phase: Prophylaxis
Other
|
0
|
1
|
0
|
|
Main Phase: Prophylaxis
Switched to ITI without completing main phase
|
0
|
2
|
0
|
|
Main Phase: Prophylaxis
Early site closure
|
0
|
2
|
0
|
|
Main Phase: Prophylaxis
Lost to Follow-up
|
0
|
1
|
0
|
|
Immune Tolerance Induction
Withdrawal by parent/guardian
|
0
|
0
|
1
|
|
Immune Tolerance Induction
Lack of Efficacy
|
0
|
0
|
1
|
|
Immune Tolerance Induction
Undergone minor surgery
|
0
|
0
|
2
|
|
Extension Phase: Prophylaxis
Adverse Event
|
0
|
1
|
0
|
|
Extension Phase: Prophylaxis
Protocol Violation
|
0
|
1
|
0
|
|
Extension Phase: Prophylaxis
Withdrawal by parent/guardian
|
0
|
1
|
0
|
|
Extension Phase: Prophylaxis
Other
|
0
|
1
|
0
|
|
Extension Phase: Prophylaxis
Early site closure
|
0
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
Baseline characteristics by cohort
| Measure |
All Participants
n=81 Participants
Participants received pre-prophylaxis treatment of N8-GP 60 IU/kg intravenous injection as slow start prophylaxis and on-demand treatment of bleeding episodes until they were 24 months of age or until 20 exposure days (ED) on pre-prophylaxis, whichever came first in the main phase. After which they switched to prophylaxis treatment. In prophylaxis, participants received N8-GP 60 IU/kg intravenous injection twice weekly with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. In the extension phase, subjects were to continue the prophylaxis dosing regimen as prescribed at the end of the main phase.
|
|---|---|
|
Age, Continuous
|
10.2 Years
STANDARD_DEVIATION 11.0 • n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment up to 7 yearsPopulation: Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.
Number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) was reported during the main and extension phase of the trial.
Outcome measures
| Measure |
Pre-prophylaxis
n=55 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=68 Participants
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII)
|
11 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on SAS. The SAS consists of all participants exposed to N8-GP.
Number of adverse events including serious adverse events and medical events of special interest reported during the main and extension phase of the trial. An adverse event (AE) is any untoward medical occurrence in a patient administered a product, and which does not necessarily have a causal relationship with this treatment. Serious adverse event (SAE) is an experience that at any dose results in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect and important medical events that may not result in death, be life threatening or require hospitalisation. Medical event of special interest (MESI) is an event which, in the evaluation of safety, has a special focus.
Outcome measures
| Measure |
Pre-prophylaxis
n=55 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=69 Participants
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
n=8 Participants
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest
Serious adverse events
|
24 Events
|
56 Events
|
3 Events
|
|
Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest
Adverse events
|
116 Events
|
644 Events
|
32 Events
|
|
Number of Adverse Events Including Serious Adverse Events and Medical Events of Special Interest
Medical events of special interest
|
17 Events
|
47 Events
|
0 Events
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on safety analysis set (SAS). The SAS consist of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.
Number of participants with confirmed high titre inhibitors (defined as inhibitor titre above 5 Bethesda Units (BU) was reported during the main and extension phase of the trial.
Outcome measures
| Measure |
Pre-prophylaxis
n=55 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=68 Participants
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Number of Participants With Confirmed High Titre Inhibitors (Defined as Inhibitor Titre Above 5 Bethesda Units (BU)
|
3 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported group. This outcome is applicable only for the reported arms.
The number of bleeding episodes per year reported during the prophylactic treatment with N8-GP was reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=69 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Number of Breakthrough Bleeding Episodes During Prophylaxis With N8-GP (Annualised Bleeding Rate)
|
1.35 bleeds/patient/year
Interval 0.6 to 3.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint.
Haemostatic effect of turoctocog alfa pegol for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hours after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms. Number of bleeding episodes in each category is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=160 Bleeds
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=345 Bleeds
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
n=8 Bleeds
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")
Excellent
|
69 Bleeding episodes
|
227 Bleeding episodes
|
2 Bleeding episodes
|
|
Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")
Good
|
62 Bleeding episodes
|
92 Bleeding episodes
|
3 Bleeding episodes
|
|
Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")
Moderate
|
18 Bleeding episodes
|
18 Bleeding episodes
|
3 Bleeding episodes
|
|
Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")
None
|
3 Bleeding episodes
|
6 Bleeding episodes
|
0 Bleeding episodes
|
|
Haemostatic Effect of N8-GP in Treatment of Bleeding Episodes, Assessed by a Predefined 4-point Haemostatic Response Scale ("Excellent", "Good", "Moderate" and "None")
Missing
|
8 Bleeding episodes
|
2 Bleeding episodes
|
0 Bleeding episodes
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported arm.
Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Average dose consumption in IU/kg during main and extension phase is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=69 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Consumption of N8-GP for Prophylaxis (International Unit Per Kilogram (IU/Kg))
|
68.9 IU/kg
Standard Deviation 7.6
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. The endpoint is applicable for only reported arm.
Consumption of N8-GP for prophylaxis is reported. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Number of injections consumption per patient during main and extension phase is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=69 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Consumption of N8-GP for Prophylaxis (Number of Injections)
|
236.6 Injections/patient
Standard Deviation 208.2
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. This outcome is applicable only for the reported arms.
Consumption of N8-GP for treatment of bleeding episodes (IU/kg/bleed) is reported. Average dose consumption in IU/kg/bleed during main and extension phase is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=55 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=69 Participants
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Consumption of N8-GP for Treatment of Bleeding Episodes (International Unit Per Kilogram Per Bleed (IU/kg/Bleed))
|
112.9 IU/kg/bleed
Standard Deviation 113.4
|
92.1 IU/kg/bleed
Standard Deviation 71.7
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP.
Consumption of N8-GP for treatment of bleeding episodes (number of injections) is reported. Number of average injections required for treatment of per bleed is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=55 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=69 Participants
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Consumption of N8-GP for Treatment of Bleeding Episodes (Number of Injections)
|
1.6 Injections/bleed
Standard Deviation 1.6
|
1.3 Injections/bleed
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). The FAS consists of all participants exposed to N8-GP. Number of participants analyzed=participants with available data for this endpoint. This outcome is applicable only for the reported arms.
Total consumption of N8-GP per patient (prevention and treatment of bleeding episodes) annualised value is presented. Consumption used for treatment includes all doses given. Yearly consumption is only calculated for patients with a exposure time of at least 30 days. Consumption used for treatment per year per patient (IU/kg/year/patient) is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=50 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=69 Participants
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Total Consumption of N8-GP Per Patient (Prevention and Treatment of Bleeding Episodes) Annualised Value
|
2108.6 IU/kg/year/patient
Standard Deviation 2697.6
|
5394.9 IU/kg/year/patient
Standard Deviation 1887.9
|
—
|
SECONDARY outcome
Timeframe: From start of the treatment up to 8.9 yearsPopulation: Results were based on full analysis set (FAS). This outcome is applicable only for the reported arm.
The outcome of ITI was evaluated by predefined 4-point outcome of ITI scale ('success', 'partial success', 'failure', 'other'). Success: An inhibitor titre less than (\<) 0.6 BU. A normalised FVIII recovery, defined as greater than or equal to (≥) 66 percentage (%) of expected incremental recovery. An N8-GP half-life (t½) ≥9 hours after a 72-hour treatment-free washout period. Partial success: Reduction in inhibitor titre to less than or equal to (≤) 5 BU. Clinical effect of N8-GP therapy as judged by the investigator. Failure: Failure to attain defined success or partial success within 24 months of uninterrupted ITI with N8-GP. Inhibitor decrease less than (\<) 20% after one year of ITI treatment. Other: Not fulfilling the above criteria. Number of participants in each category is reported.
Outcome measures
| Measure |
Pre-prophylaxis
n=8 Participants
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Outcome of ITI, Assessed by a Predefined 4-point ITI Outcome Scale ("Success", "Partial Success", "Failure", "Other")
Success
|
4 Participants
|
—
|
—
|
|
Outcome of ITI, Assessed by a Predefined 4-point ITI Outcome Scale ("Success", "Partial Success", "Failure", "Other")
Partial success
|
2 Participants
|
—
|
—
|
|
Outcome of ITI, Assessed by a Predefined 4-point ITI Outcome Scale ("Success", "Partial Success", "Failure", "Other")
Failure
|
2 Participants
|
—
|
—
|
Adverse Events
Pre-prophylaxis
Serious events: 18 serious events
Other events: 28 other events
Deaths: 0 deaths
Prophylaxis
Serious events: 34 serious events
Other events: 51 other events
Deaths: 0 deaths
Immune Tolerance Induction (ITI)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-prophylaxis
n=55 participants at risk
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=69 participants at risk
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
n=8 participants at risk
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Investigations
Anti factor VIII antibody positive
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
2.9%
2/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Bronchiolitis
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Product Issues
Device issue
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Device related infection
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
18.2%
10/55 • Number of events 10 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
17.4%
12/69 • Number of events 13 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Nervous system disorders
Febrile convulsion
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Vascular disorders
Haematoma
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Head injury
|
3.6%
2/55 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Investigations
Heart rate increased
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Influenza
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
General disorders
Pyrexia
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
2.9%
2/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Nervous system disorders
Seizure
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Sepsis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Nervous system disorders
Spinal epidural haematoma
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
General disorders
Therapy non-responder
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Surgical and medical procedures
Urethral repair
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Surgical and medical procedures
Urogenital fistula repair
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
General disorders
Vaccination site haemorrhage
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
Other adverse events
| Measure |
Pre-prophylaxis
n=55 participants at risk
At the beginning of the main phase of the trial, slow start prophylaxis and on-demand treatment of bleeding episodes with trial product (Turoctocog alfa pegol (N8-GP)) were allowed at the discretion of the investigator and participants parent(s)/ legally acceptable representative (LAR). The N8-GP dose for pre-prophylaxis treatment (except for bleeding episodes) was 60 International unit per kilogram (IU/kg) body weight (within the range of 50-75 IU/kg) to be administered as a single bolus dose intravenously (i.v.) with more than one week between doses (at the discretion of the investigator). Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Prophylaxis
n=69 participants at risk
For prophylaxis treatment, regular N8-GP administration was initiated no later than at the participants age of 24 months, or after 20 EDs on pre-prophylaxis, whatever came first. During the main phase of the trial, participants received prophylaxis with i.v. injections of N8-GP preferably twice weekly, with doses separated by at least 3, and no more than 4, calendar days. Furthermore, it was permissible to start prophylaxis in the main phase with an every 3rd day or once-weekly dosing regimen. The N8-GP dose for prophylaxis treatment was 60 IU/kg (within the range of 50-75 IU/kg) to be administered as a single bolus dose i.v. on each administration day. Participants who developed FVIII inhibitors in the trial were shifted to ITI treatment.
|
Immune Tolerance Induction (ITI)
n=8 participants at risk
Participants who developed FVIII inhibitors in the trial were offered ITI treatment with N8-GP. If a newly diagnosed inhibitor participant still responded well to treatment with N8-GP, initiation of ITI could be postponed with up to 6 months, or ITI could be cancelled if the inhibitors had resolved during the 6 months. N8-GP treatment could continue in case of low titre FVIII inhibitor (lesser than or equal (≤) 5 Bethesda Units). In case of high titre FVIII inhibitor (greater than (\>) 5 Bethesda Units), the investigator had to decide how to proceed with treatment. ITI with N8-GP had to be initiated within 6 months of the confirmatory inhibitor test. The N8-GP dose for ITI treatment was according to local standard. Maximum of 75 IU/kg as single dose, maximum of 200 IU/kg over 24 hours.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
8.7%
6/69 • Number of events 6 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
2/55 • Number of events 3 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Investigations
Anti factor VIII antibody positive
|
5.5%
3/55 • Number of events 3 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
7.2%
5/69 • Number of events 6 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.5%
3/55 • Number of events 5 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
7.2%
5/69 • Number of events 72 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
3/55 • Number of events 3 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
13.0%
9/69 • Number of events 13 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Cardiac disorders
Cyanosis
|
7.3%
4/55 • Number of events 4 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
8.7%
6/69 • Number of events 9 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Ear infection
|
5.5%
3/55 • Number of events 7 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
13.0%
9/69 • Number of events 13 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
5.8%
4/69 • Number of events 6 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
13.0%
9/69 • Number of events 10 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
4.3%
3/69 • Number of events 3 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Influenza
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
8.7%
6/69 • Number of events 7 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
6/55 • Number of events 7 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
31.9%
22/69 • Number of events 80 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 5 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Otitis media
|
3.6%
2/55 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
5.8%
4/69 • Number of events 6 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Pharyngitis
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
7.2%
5/69 • Number of events 8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
5.8%
4/69 • Number of events 4 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
General disorders
Pyrexia
|
9.1%
5/55 • Number of events 6 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
37.7%
26/69 • Number of events 75 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
25.0%
2/8 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
7.2%
5/69 • Number of events 10 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
10.1%
7/69 • Number of events 13 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Tonsillitis
|
3.6%
2/55 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
8.7%
6/69 • Number of events 8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
1.4%
1/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 3 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.7%
7/55 • Number of events 8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
23.2%
16/69 • Number of events 35 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
25.0%
2/8 • Number of events 3 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Varicella
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
2.9%
2/69 • Number of events 2 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Infections and infestations
Viral infection
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
7.2%
5/69 • Number of events 5 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/8 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
7.2%
5/69 • Number of events 10 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
|
Injury, poisoning and procedural complications
Vaccine complication
|
0.00%
0/55 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
0.00%
0/69 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
12.5%
1/8 • Number of events 1 • From start of the treatment up to 8.9 years
All the presented adverse events (AEs) are treatment emergent adverse events (TEAEs). AEs occurring in a patient before being exposed to N8-GP. Safety analysis set included all patients exposed to N8-GP. Collective data for main and extension phase is reported for each group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER