Trial Outcomes & Findings for A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A (NCT NCT02615691)
NCT ID: NCT02615691
Last Updated: 2025-07-28
Results Overview
Number of participants who developed an inhibitor (at any time) confirmed by a central laboratory based on a second repeat blood sample draw within 2 weeks of site notification of an inhibitor and all participants who had not developed an inhibitor and had greater than or equal to (\>=) 100 EDs when the sample for the last valid inhibitor test was drawn.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
Throughout Part A of the study, approximately 5 years
Results posted on
2025-07-28
Participant Flow
Participants took part in the study at various investigative sites globally from 12 November 2015 to 29 October 2024.
Previously untreated patients (PUPs) \<6 years with severe hemophilia A (Factor VIII \[FVIII\] \<1%) were treated with BAX 855 in Part A of this study for at least 100 exposure days (EDs) or until they had developed a confirmed FVIII inhibitor. Then, participants who developed high or low titer FVIII inhibitors entered Part B. In Part B they underwent immune tolerance induction (ITI) with BAX 855.
Participant milestones
| Measure |
All Participants
PUPs \< 6 years of age with severe hemophilia A (FVIII \< 1%) and \< 3 EDs to ADVATE, BAX 855 or plasma transfusion were enrolled in a single arm group.
Part A (Main Study): Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 international units per kilogram (IU/kg) intravenously (IV) depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
Part B (ITI Portion): Participants who met the pre-defined Part B treatment criteria entered Part B of the study for ITI. Participants either received prophylaxis treatment of BAX 855 low dose 50 IU/kg IV, three times a week or high dose 100-200 IU/kg IV, daily at the discretion of the investigator according to the institution's standard of care.
|
|---|---|
|
Part A: Main Study (5 Years)
STARTED
|
120
|
|
Part A: Main Study (5 Years)
Part A: On-demand Treatment
|
80
|
|
Part A: Main Study (5 Years)
Part A: Prophylaxis Treatment
|
112
|
|
Part A: Main Study (5 Years)
COMPLETED
|
106
|
|
Part A: Main Study (5 Years)
NOT COMPLETED
|
14
|
|
Part B: ITI Portion (3.5 Years)
STARTED
|
7
|
|
Part B: ITI Portion (3.5 Years)
Part B:FVII Inhibitor Treatment(50IU/kg 3 Times Weekly Regimen)
|
4
|
|
Part B: ITI Portion (3.5 Years)
Part B:FVII Inhibitor Treatment (100-200IU/kg Daily Regimen)
|
3
|
|
Part B: ITI Portion (3.5 Years)
COMPLETED
|
7
|
|
Part B: ITI Portion (3.5 Years)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Participants
PUPs \< 6 years of age with severe hemophilia A (FVIII \< 1%) and \< 3 EDs to ADVATE, BAX 855 or plasma transfusion were enrolled in a single arm group.
Part A (Main Study): Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 international units per kilogram (IU/kg) intravenously (IV) depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
Part B (ITI Portion): Participants who met the pre-defined Part B treatment criteria entered Part B of the study for ITI. Participants either received prophylaxis treatment of BAX 855 low dose 50 IU/kg IV, three times a week or high dose 100-200 IU/kg IV, daily at the discretion of the investigator according to the institution's standard of care.
|
|---|---|
|
Part A: Main Study (5 Years)
Adverse Event
|
3
|
|
Part A: Main Study (5 Years)
Physician Decision
|
2
|
|
Part A: Main Study (5 Years)
Withdrawal by Subject
|
7
|
|
Part A: Main Study (5 Years)
Reason Not Specified
|
2
|
Baseline Characteristics
A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A
Baseline characteristics by cohort
| Measure |
All Participants
n=120 Participants
PUPs \< 6 years of age with severe hemophilia A (FVIII \< 1%) and \< 3 EDs to ADVATE, BAX 855 or plasma transfusion were enrolled in a single arm group.
Part A (Main Study): Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 international units per kilogram (IU/kg) intravenously (IV) depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
Part B (ITI Portion): Participants who met the pre-defined Part B treatment criteria entered Part B of the study for ITI. Participants either received prophylaxis treatment of BAX 855 low dose 50 IU/kg IV, three times a week or high dose 100-200 IU/kg IV, daily at the discretion of the investigator according to the institution's standard of care.
|
|---|---|
|
Age, Continuous
|
0.90 years
STANDARD_DEVIATION 0.717 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout Part A of the study, approximately 5 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion. Included in the analysis were participants who had equal or greater than 100 EDs or developed a confirmed FVIII inhibitor.
Number of participants who developed an inhibitor (at any time) confirmed by a central laboratory based on a second repeat blood sample draw within 2 weeks of site notification of an inhibitor and all participants who had not developed an inhibitor and had greater than or equal to (\>=) 100 EDs when the sample for the last valid inhibitor test was drawn.
Outcome measures
| Measure |
Part A: Main Study
n=100 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants With FVIII Inhibitor Development
|
11 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 33 months in Part B of the studyPopulation: The FVIII Inhibitor Treatment Analysis Set (IAS) included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment.
Success is defined as 1) a persistently negative inhibitor titer less than (\<) 0.6 Bethesda unit (BU), 2) FVIII IR \>=66% of the baseline value following a wash-out period of 84-96 hours, and 3) a FVIII half-life of \>=6 hours.
Outcome measures
| Measure |
Part A: Main Study
n=7 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants With Success of Immune Tolerance Induction (ITI)
|
5 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A of the study, approximately 5 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion. Number analyzed is the number of participants with data available for analyses.
Binding IgG and IgM antibodies to FVIII , Factor VIII-Polyethylene glycol (PEG-FVIII) and Polyethylene glycol (PEG) was assessed. A participant that received on-demand treatment first and then moved to prophylaxis treatment was counted for both on-demand and prophylaxis regimens. A participant that started with prophylaxis treatment was counted only for the prophylaxis regimen even if the participant received on-demand treatment while on the prophylaxis regimen. Visits and their approximate time in weeks after baseline visit for individual participants: Visit 1(Week 5), Visit 2 (Week 10), Visit 3 (Week 15), Visit 4 (Week 20), Visit 5 (Week 30), Visit 6 (Week 40), Visit 7 (Week 55), Visit 8 (Week 75) and Study Completion Visit (Weeks 100-110).
Outcome measures
| Measure |
Part A: Main Study
n=80 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=112 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgG Antibodies to FVIII
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgG Antibodies to PEG-FVIII
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgM Antibodies to PEG-FVIII
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgM Antibodies to PEG
|
6 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Baseline- Binding IgG Antibodies to FVIII
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Baseline- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Baseline- Binding IgG Antibodies to PEG-FVIII
|
7 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Baseline- Binding IgM Antibodies to PEG-FVIII
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Baseline- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Baseline- Binding IgM Antibodies to PEG
|
8 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1- Binding IgG Antibodies to FVIII
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1- Binding IgG Antibodies to PEG-FVIII
|
14 Participants
|
36 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1- Binding IgG Antibodies to PEG
|
4 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1- Binding IgM Antibodies to PEG
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2- Binding IgG Antibodies to FVIII
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2- Binding IgG Antibodies to PEG-FVIII
|
6 Participants
|
27 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2- Binding IgG Antibodies to PEG
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 3- Binding IgG Antibodies to FVIII
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 3- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 3- Binding IgG Antibodies to PEG-FVIII
|
4 Participants
|
25 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 3- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 3- Binding IgG Antibodies to PEG
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 3- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 4- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 4- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 4- Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
18 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 4- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 4- Binding IgG Antibodies to PEG
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 4- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 5- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 5- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 5- Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 5- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 5- Binding IgG Antibodies to PEG
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 5- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 6- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 6- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 6- Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 6- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 6- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 6- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 7- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 7- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 7- Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 7- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 7- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 7- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 8- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 8- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 8- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 8- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 8- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 8- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Study Completion- Binding IgG Antibodies to FVIII
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Study Completion- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Study Completion-Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Study Completion- Binding IgM Antibodies to PEG-FVIII
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Study Completion- Binding IgG Antibodies to PEG
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Study Completion- Binding IgM Antibodies to PEG
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A and Part B of the study, approximately 9 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion for Part A of the study and the IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment for Part B of the study.
An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose) which results in death, is life-threatening, requires inpatient hospitalization, prolongation of hospitalization, is an important medical event. Number of participants with AEs and SAEs in both Part A and Part B were assessed. A participant that received on-demand treatment first and then moved to prophylaxis treatment was counted for both on-demand and prophylaxis regimens. A participant that started with prophylaxis treatment was counted only for the prophylaxis regimen even if the participant received on-demand treatment while on the prophylaxis regimen.
Outcome measures
| Measure |
Part A: Main Study
n=80 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=112 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
n=4 Participants
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
n=3 Participants
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
57 Participants
|
94 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
18 Participants
|
35 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Throughout Part A and Part B of the study, approximately 9 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion for Part A of the study and the IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment for Part B of the study.
Vital signs were assessed based on body temperature, respiratory rate, blood pressure, and heart rate.
Outcome measures
| Measure |
Part A: Main Study
n=120 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=7 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Clinically Significant Changes in Vital Signs
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A and Part B of the study, approximately 9 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion for Part A of the study and the IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment for Part B of the study.
Clinical laboratory parameters included hematology and clinical chemistry. Changes in laboratory values could be considered as AE if they were judged to be clinically significant.
Outcome measures
| Measure |
Part A: Main Study
n=120 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=7 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Clinically Significant Changes in Clinical Laboratory Parameters
|
53 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A and Part B of the study, approximately 9 yearsPopulation: The SAS used for included all participants in the enrolled population with at least one BAX 855 infusion for Part A of the study and the IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment for Part B of the study.
ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. Bleeding occurring at multiple locations related to the same injury (example, knee and ankle bleed following a fall) was counted as a single bleeding episode. Mean total annualized bleed rate is reported. A participant that received on-demand treatment first and then moved to prophylaxis treatment was counted for both on-demand and prophylaxis regimens. A participant that started with prophylaxis treatment was counted only for the prophylaxis regimen even if the participant received on-demand treatment while on the prophylaxis regimen.
Outcome measures
| Measure |
Part A: Main Study
n=80 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=112 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
n=4 Participants
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
n=3 Participants
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Annualized Bleeding Rate (ABR) for Prophylactic and On-demand Treatment and Immune Tolerance Induction (ITI)
|
10.004 unique bleeds per year
Standard Deviation 15.533
|
4.536 unique bleeds per year
Standard Deviation 8.657
|
7.673 unique bleeds per year
Standard Deviation 8.965
|
6.432 unique bleeds per year
Standard Deviation 14.518
|
SECONDARY outcome
Timeframe: Throughout Part A of the study, approximately 5 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion.
A bleeding episode is defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The number of BAX 855 infusions needed for each bleeding episode was determined by the participant, caregiver, clinician treating the participant, and is based upon the participant's response to treatment, using the Efficacy Rating Scale for Treatment of Bleeding Episodes. Number of bleeding episodes are categorized by number of infusions required to treat the bleeding episodes. A participant that received on-demand treatment first and then moved to prophylaxis treatment was counted for both on-demand and prophylaxis regimens. A participant that started with prophylaxis treatment was counted only for the prophylaxis regimen even if the participant received on-demand treatment while on the prophylaxis regimen.
Outcome measures
| Measure |
Part A: Main Study
n=379 Number of treated bleeds
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=396 Number of treated bleeds
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Bleeding Episodes Categorized by Number of BAX 855 Infusions Required for Treatment
Number of infusions per bleed: 0
|
7 bleeding episodes
|
14 bleeding episodes
|
—
|
—
|
|
Bleeding Episodes Categorized by Number of BAX 855 Infusions Required for Treatment
Number of infusions per bleed: 1
|
302 bleeding episodes
|
312 bleeding episodes
|
—
|
—
|
|
Bleeding Episodes Categorized by Number of BAX 855 Infusions Required for Treatment
Number of infusions per bleed: 2
|
43 bleeding episodes
|
44 bleeding episodes
|
—
|
—
|
|
Bleeding Episodes Categorized by Number of BAX 855 Infusions Required for Treatment
Number of infusions per bleed: 3
|
18 bleeding episodes
|
19 bleeding episodes
|
—
|
—
|
|
Bleeding Episodes Categorized by Number of BAX 855 Infusions Required for Treatment
Number of infusions per bleed: 4
|
4 bleeding episodes
|
1 bleeding episodes
|
—
|
—
|
|
Bleeding Episodes Categorized by Number of BAX 855 Infusions Required for Treatment
Number of infusions per bleed: >4
|
5 bleeding episodes
|
6 bleeding episodes
|
—
|
—
|
SECONDARY outcome
Timeframe: At 24 hours after study drug administration during Part A of the studyPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion. The number of units analyzed indicates the number of treated bleeds for which efficacy rating at 24 hours after initiation of treatment was available.
The participant or caregiver rated overall treatment response using a 4-point efficacy rating scale as Excellent:Full relief of pain \& cessation of objective signs of bleeding after single infusion \& no additional infusion is required for the control of bleeding; Good:Definite pain relief \&/or improvement in signs of bleeding after single infusion \& possibly requires more than 1 infusion for complete resolution; Fair:Probable \&/or slight relief of pain \& slight improvement in signs of bleeding after single infusion \& required more than 1 infusion for complete resolution \& None:No improvement or condition worsens.Number of bleeds with each efficacy rating are reported.Participant that received on-demand treatment first \& then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens.Participant that started with prophylaxis treatment was counted only for the prophylaxis regimen even if the participant received on-demand treatment while on prophylaxis regimen.
Outcome measures
| Measure |
Part A: Main Study
n=158 Number of treated bleeds
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=184 Number of treated bleeds
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at 24 Hours After Initiation of Treatment
Excellent
|
76 bleeds
|
102 bleeds
|
—
|
—
|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at 24 Hours After Initiation of Treatment
Good
|
67 bleeds
|
71 bleeds
|
—
|
—
|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at 24 Hours After Initiation of Treatment
Fair
|
13 bleeds
|
10 bleeds
|
—
|
—
|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at 24 Hours After Initiation of Treatment
None
|
2 bleeds
|
1 bleeds
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to bleed resolution throughout Part A of the study (up to approximately 5 years)Population: The SAS included all participants in the enrolled population with at least one BAX 855 infusion. The number of units analyzed indicates the number of treated bleeds for which overall efficacy rating was available.
The participant or caregiver rated overall treatment response using a 4-point efficacy rating scale as Excellent:Full relief of pain \& cessation of objective signs of bleeding after single infusion \& no additional infusion is required for the control of bleeding; Good:Definite pain relief \&/or improvement in signs of bleeding after a single infusion \& possibly requires more than 1 infusion for complete resolution; Fair:Probable \&/or slight relief of pain \& slight improvement in signs of bleeding after single infusion \& required more than 1 infusion for complete resolution \& None:No improvement or condition worse.Number of bleeds with each efficacy rating are reported.Participant that received on-demand treatment first \& then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens.Participant that started with prophylaxis treatment was counted only for prophylaxis regimen even if the participant received on-demand treatment while on prophylaxis regimen.
Outcome measures
| Measure |
Part A: Main Study
n=264 Number of treated bleeds
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=253 Number of treated bleeds
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at Bleed Resolution
Excellent
|
166 bleeds
|
166 bleeds
|
—
|
—
|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at Bleed Resolution
Good
|
83 bleeds
|
77 bleeds
|
—
|
—
|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at Bleed Resolution
Fair
|
12 bleeds
|
9 bleeds
|
—
|
—
|
|
Number of Bleeds by Overall Hemostatic Efficacy Rating at Bleed Resolution
None
|
3 bleeds
|
1 bleeds
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A of the study, approximately 5 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion. Number analyzed for each category is the number of participants with data available for analyses.
Weight-adjusted consumption of BAX 855 was determined based upon the record in participants diaries of the actual amount of BAX 855 infused as measured in the clinic. Average dose per prophylactic infusion, per month and per year are reported as categories.
Outcome measures
| Measure |
Part A: Main Study
n=112 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Weight-adjusted Consumption of BAX 855: Average Prophylactic Dose
Average Dose [IU/kg] per Prophylactic Infusion
|
45.514 IU/kg
Standard Deviation 7.831
|
—
|
—
|
—
|
|
Weight-adjusted Consumption of BAX 855: Average Prophylactic Dose
Average Prophylactic Dose [IU/kg] per Month
|
221.568 IU/kg
Standard Deviation 85.925
|
—
|
—
|
—
|
|
Weight-adjusted Consumption of BAX 855: Average Prophylactic Dose
Average Prophylactic Dose [IU/kg] per Year
|
2597.079 IU/kg
Standard Deviation 783.089
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A and Part B of the study, approximately 9 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion. Number analyzed for each category is the number of participants with data available for analyses.
Weight-adjusted consumption of BAX 855 was determined based upon the record in participants diaries of the actual number of BAX 855 infusions as measured in the clinic. Average number of infusions per month and year are reported as categories.
Outcome measures
| Measure |
Part A: Main Study
n=112 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Weight-adjusted Consumption of BAX 855: Average Number of Prophylactic Infusions
Average Number of Prophylactic Infusions per Month
|
4.900 infusions
Standard Deviation 1.877
|
—
|
—
|
—
|
|
Weight-adjusted Consumption of BAX 855: Average Number of Prophylactic Infusions
Average Number of Prophylactic Infusions per Year
|
57.067 infusions
Standard Deviation 16.361
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout Part A of the study, approximately 5 yearsPopulation: The SAS included all participants in the enrolled population with at least one BAX 855 infusion for Part A of the study and the IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment for Part B of the study. Number analyzed for each category is the number of participants with data available for analyses.
Weight-adjusted consumption of BAX 855 was determined based upon the record in participants diaries of the actual amount of BAX 855 infused as measured in the clinic. Average dose to treat bleeding episode and average FVIII inhibitor treatment Dose \[IU/kg\] per Week, Month and per Year are reported as categories. A participant that received on-demand treatment first and then moved to prophylaxis treatment was counted for both on-demand and prophylaxis regimens. A participant that started with prophylaxis treatment was counted only for the prophylaxis regimen even if the participant received on-demand treatment while on the prophylaxis regimen.
Outcome measures
| Measure |
Part A: Main Study
n=80 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=112 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
n=4 Participants
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
n=3 Participants
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Weight-adjusted Consumption of BAX 855: Average Dose
Average FVIII Inhibitor Treatment Dose [IU/kg] per Year
|
—
|
—
|
6444.460 IU/kg
Standard Deviation 3420.911
|
21797.128 IU/kg
Standard Deviation 16680.821
|
|
Weight-adjusted Consumption of BAX 855: Average Dose
Average Dose [IU/kg] to Treat Bleeding Episode
|
55.445 IU/kg
Standard Deviation 32.826
|
63.864 IU/kg
Standard Deviation 44.818
|
—
|
—
|
|
Weight-adjusted Consumption of BAX 855: Average Dose
Average FVIII Inhibitor Treatment Dose [IU/kg] per Week
|
—
|
—
|
123.510 IU/kg
Standard Deviation 65.563
|
417.750 IU/kg
Standard Deviation 319.694
|
|
Weight-adjusted Consumption of BAX 855: Average Dose
Average FVIII Inhibitor Treatment Dose [IU/kg] per Month
|
—
|
—
|
537.038 IU/kg
Standard Deviation 285.076
|
1816.427 IU/kg
Standard Deviation 1390.068
|
SECONDARY outcome
Timeframe: Surgery Day 0 up to postoperative Day 14 or discharge (whichever occurs first)Population: The Invasive Procedure Analysis Set (IPRAS) included all participants who were treated with BAX 855 for one or more surgeries or invasive procedures in the context of the study. Number of participants analyzed is the number of participants with data available for analyses.
Hemostatic efficacy was assessed during \& after any surgical or invasive procedures,\& overall as a perioperative assessment.Operating surgeon assessed hemostatic efficacy compared to that expected for the type of procedure performed in non-hemophilic population,prior to discharge from recovery room(intraoperative),on postoperative Day 1 \& at discharge or 14 days post-surgery(perioperative).Participants rated efficacy using following ratings:1.Excellent:Postoperative blood loss was ≤100% than expected;2.Good:Postoperative blood loss was up to 50% more (101-150%) than expected;3.Fair:Postoperative blood loss was more than 50% (\>150%) of that expected;4.None:Significant postoperative bleeding that was result of inadequate therapeutic response despite proper dosing,necessitating rescue therapy.Perioperative ratings also considered amount of blood components required for transfusions compared to expected.Participant-provided ratings for each of the assessments are reported as categories.
Outcome measures
| Measure |
Part A: Main Study
n=37 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Intraoperative - Excellent
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Intraoperative - Good
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Intraoperative - Fair
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Intraoperative - None
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Postoperative - Excellent
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Postoperative - Good
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Postoperative - Fair
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Postoperative - None
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Perioperative - Excellent
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Perioperative - Good
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Perioperative - Fair
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants by Hemostatic Efficacy Rating in Case of Surgery
Perioperative - None
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Surgery Day 0 up to postoperative Day 14 or discharge (whichever occurs first)Population: The IPRAS included all participants who were treated with BAX 855 for one or more surgeries or invasive procedures in the context of the study. Number analyzed are the participants who experienced blood loss.
The intraoperative blood loss was measured by determining the volume of blood and fluid removal through suction into the collection container (waste box and/or cell saver) and the estimated blood loss into swabs and towels during the procedure, per the anesthesiologist's record. Post-operatively, blood loss was determined by the drainage volume collected, which mainly consisted of drainage fluid via vacuum or gravity drain, as applicable. The assessment was done for the intra-operative time period (prior to discharge from recovery room) and for the post-operative time period (from completion of the procedure until approximately 24 hours post-surgery).
Outcome measures
| Measure |
Part A: Main Study
n=37 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Blood Loss Per Participant in Case of Surgery
Observed Intra-Operative Blood Loss
|
4.8 milliliters (mL)
Standard Deviation 5.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Study Completion (Up to 5 years in Part A and up to 3.5 years in Part B)Population: The Pharmacokinetic (PK) analysis set (PKAS) included all participants in the SAS who had at least one post-dose measurement of FVIII activity without protocol deviations and/or events with potential to affect concentration (FVIII activity levels). Number analyzed is the number of participants with data available for analyses.
BAX 855 was administered in participants for the determination of FVIII IR at study site at baseline \& every study visit other than study visits at 5 EDs, 15 EDs \& 30 EDs. FVIII assays were done using following methods:1-stage clotting FVIII activity \& FVIII chromogenic activity. Data is reported for each of these methods as categories per visit. Study Completion assessment was conducted at end of the Main Study \& again at end of the ITI portion. Thus, more number of participants were analyzed at study completion visit than those who actually completed the overall study. IR is reported as a ratio of (IU/deciliter \[dL\])/(IU/kg), calculated as: IR = (Cmax- (C pre-infusion)) / (IU/kg), where C=concentration. Visits and their approximate time in weeks after baseline visit for individual participants: Visit 1 (Week 5), Visit 2 (Week 10), Visit 3 (Week 15), Visit 4 (Week 20), Visit 5 (Week 30), Visit 6 (Week 40), Visit 7 (Week 55), Visit 8 (Week 75) \& Study Completion Visit (Weeks 100-110).
Outcome measures
| Measure |
Part A: Main Study
n=119 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Incremental Recovery (IR) of BAX 855
Baseline-1-Stage Clotting
|
1.546 ratio
Geometric Coefficient of Variation 46.991
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Baseline-Chromogenic
|
1.594 ratio
Geometric Coefficient of Variation 55.555
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 1-1-Stage Clotting
|
1.452 ratio
Geometric Coefficient of Variation 49.680
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 1-Chromogenic
|
1.651 ratio
Geometric Coefficient of Variation 43.755
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 2-1-Stage Clotting
|
1.345 ratio
Geometric Coefficient of Variation 72.207
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 2-Chromogenic
|
1.451 ratio
Geometric Coefficient of Variation 57.891
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 3-1-Stage Clotting
|
1.439 ratio
Geometric Coefficient of Variation 61.369
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 3-Chromogenic
|
1.586 ratio
Geometric Coefficient of Variation 54.653
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 4-1-Stage Clotting
|
1.558 ratio
Geometric Coefficient of Variation 33.938
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 4-Chromogenic
|
1.802 ratio
Geometric Coefficient of Variation 31.897
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 5-1-Stage Clotting
|
1.588 ratio
Geometric Coefficient of Variation 51.122
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 5-Chromogenic
|
1.916 ratio
Geometric Coefficient of Variation 28.373
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 6-1-Stage Clotting
|
1.714 ratio
Geometric Coefficient of Variation 34.037
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 6-Chromogenic
|
1.809 ratio
Geometric Coefficient of Variation 46.022
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 7-1-Stage Clotting
|
1.742 ratio
Geometric Coefficient of Variation 46.707
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 7-Chromogenic
|
1.965 ratio
Geometric Coefficient of Variation 20.272
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 8-1-Stage Clotting
|
1.634 ratio
Geometric Coefficient of Variation 43.470
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Visit 8-Chromogenic
|
1.893 ratio
Geometric Coefficient of Variation 36.334
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Study Completion-1-Stage Clotting
|
1.819 ratio
Geometric Coefficient of Variation 25.513
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Study Completion-Chromogenic
|
1.979 ratio
Geometric Coefficient of Variation 23.846
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Preoperative Assessments Surgery-1-Stage Clotting
|
1.481 ratio
Geometric Coefficient of Variation 42.457
|
—
|
—
|
—
|
|
Incremental Recovery (IR) of BAX 855
Preoperative Assessments Surgery-Chromogenic
|
1.716 ratio
Geometric Coefficient of Variation 45.340
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, Post-infusion: 15-30 minutes and 24-48 hours at BaselinePopulation: As pre-specified in the protocol, the determination of FVIII half-life by abbreviated PK at baseline was optional and was not performed.
The Half-life to determine FVIII half-life was an optional assessment that was planned to be performed at baseline, Visit 1, or Visit 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 33 months in Part B of the studyPopulation: FVIII inhibitor treatment analysis set (IAS) included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment.
Partial success defined as which meet two of following criteria, 1) inhibitor titer \<0.6 BU (confirmed by a central laboratory with a second blood specimen obtained within 2 months), 2) FVIII in vivo recovery \>=66% of baseline value (confirmed within a two month period), and 3) FVIII half-life \>=6 hours. Failure defined as the failure to meet the criteria for partial success.
Outcome measures
| Measure |
Part A: Main Study
n=7 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Immune Tolerance Induction (ITI) - Number of Participants With Partial Success and Failure of ITI
Partial Success
|
1 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Partial Success and Failure of ITI
Failure
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33 months in Part B of the studyPopulation: IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment for Part B of the study.
Number of participants with catheter-related complications are reported.
Outcome measures
| Measure |
Part A: Main Study
n=4 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=3 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Immune Tolerance Induction (ITI) - Number of Participants With At Least One Catheter-related Complication
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33 months in Part B of the studyPopulation: The IAS included all participants who received at least one FVIII inhibitor treatment with BAX 855 during the study after the date that participant moved to FVIII inhibitor treatment.
Binding IgG and IgM antibodies to Factor VIII (FVIII), Factor VIII-Polyethylene glycol (PEG-FVIII) and Polyethylene glycol (PEG) are reported as categories per visit.
Outcome measures
| Measure |
Part A: Main Study
n=4 Participants
Participants age \<3 years - who had not experienced two joint bleeds received on-demand treatment of 10-80 IU/kg IV depending on the severity of the bleeding episode; and - who experienced maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part A: Main Study: Prophylaxis
n=3 Participants
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgG Antibodies to FVIII
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgG Antibodies to PEG
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Screening- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
First Infusion- Binding IgG Antibodies to FVIII
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
First Infusion- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
First Infusion- Binding IgG Antibodies to PEG-FVIII
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
First Infusion- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
First Infusion- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
First Infusion- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1 (Week 2) - Binding IgG Antibodies to FVIII
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1 (Week 2) - Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1 (Week 2) - Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1 (Week 2) - Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1 (Week 2) - Binding IgG Antibodies to PEG
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 1 (Week 2) - Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2 (Week 4) - Binding IgG Antibodies to FVIII
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2 (Week 4) - Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2 (Week 4) - Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2 (Week 4) - Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2 (Week 4) - Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Visit 2 (Week 4) - Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 1- Binding IgG Antibodies to FVIII
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 1- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 1- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 1- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 1- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 1- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 2- Binding IgG Antibodies to FVIII
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 2- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 2- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 2- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 2- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 2- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 3- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 3- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 3- Binding IgG Antibodies to PEG-FVIII
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 3- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 3- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 3- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 4- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 4-Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 4-Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 4-Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 5- Binding IgG Antibodies to FVIII
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 5- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 5- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 5- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 5- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 5- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 6- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 6- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 6- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 6- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 6- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 6- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 7-Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 7-Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 7-Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 7-Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 7-Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 7-Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 8-Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 8-Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 8-Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 8-Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 8-Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 8-Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 9-Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 9-Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 9-Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 9-Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 9-Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 9-Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 10- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 10- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 10- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 10- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 10- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 10- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 11- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 11- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 11- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 11- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 11- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 11- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 12- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 12- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 12- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 12- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 12- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 12- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 13- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 13- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 13- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 13- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 13- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 13- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 14- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 14- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 14- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 14- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 14- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 14- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 15- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 15- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 15- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 15- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 15- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 15- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 16- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 16- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 16- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 16- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 16- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 16- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 17- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 17- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 17- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 17- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 17- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 17- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 18- Binding IgG Antibodies to FVIII
|
0 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 18- Binding IgM Antibodies to FVIII
|
0 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 18- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 18- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 18- Binding IgG Antibodies to PEG
|
0 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 18- Binding IgM Antibodies to PEG
|
0 Participants
|
—
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 19- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 19- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 19- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 19- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 19- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
Follow-Up Visit Month 19- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
FVIII Inhibitor Treatment Completion- Binding IgG Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
FVIII Inhibitor Treatment Completion- Binding IgM Antibodies to FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
FVIII Inhibitor Treatment Completion- Binding IgG Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
FVIII Inhibitor Treatment Completion- Binding IgM Antibodies to PEG-FVIII
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
FVIII Inhibitor Treatment Completion- Binding IgG Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Immune Tolerance Induction (ITI) - Number of Participants With Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Antibodies
FVIII Inhibitor Treatment Completion- Binding IgM Antibodies to PEG
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Part A: Main Study: On-demand
Serious events: 18 serious events
Other events: 47 other events
Deaths: 0 deaths
Part A: Main Study: Prophylaxis
Serious events: 35 serious events
Other events: 77 other events
Deaths: 0 deaths
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Main Study: On-demand
n=80 participants at risk
Participants age \<3 years and who had not experienced two joint bleeds received on-demand treatment of 10-80IU/kg of BAX 855 IV depending on the severity of the bleeding episode.
|
Part A: Main Study: Prophylaxis
n=112 participants at risk
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
n=4 participants at risk
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
n=3 participants at risk
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Blood and lymphatic system disorders
Factor VIII inhibition
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
5.4%
6/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
1.8%
2/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Vascular disorders
Haematoma
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
2.7%
3/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Vascular disorders
Haemorrhage
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
2.5%
2/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
1.8%
2/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Pneumonia influenzal
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
3.6%
4/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Eye disorders
Strabismus
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Systemic viral infection
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.89%
1/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
General disorders
Vascular device occlusion
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
Other adverse events
| Measure |
Part A: Main Study: On-demand
n=80 participants at risk
Participants age \<3 years and who had not experienced two joint bleeds received on-demand treatment of 10-80IU/kg of BAX 855 IV depending on the severity of the bleeding episode.
|
Part A: Main Study: Prophylaxis
n=112 participants at risk
Participants age \<3 years or after a maximum of two joint bleeds received prophylaxis treatment with dose of 25-80 IU/kg of BAX 855 IV (based on investigator discretion) once weekly for up to 100 EDs.
|
Part B: ITI Portion (50 IU/kg Three Times Weekly Regimen)
n=4 participants at risk
Participants received prophylaxis treatment of 50 IU/kg BAX 855 IV three times in a week.
|
Part B: ITI Portion (100-200 IU/kg Daily Regimen)
n=3 participants at risk
Participants received prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
1.8%
2/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Investigations
Bacillus test positive
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
COVID-19
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
4.5%
5/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
1.8%
2/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
7/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
14.3%
16/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
8.0%
9/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Ear infection
|
5.0%
4/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
6.2%
7/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
3/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
6.2%
7/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
2.7%
3/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Influenza
|
3.8%
3/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
7.1%
8/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
5.4%
6/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
6/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
16.1%
18/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
50.0%
2/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Otitis media
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
6.2%
7/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
5.4%
6/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
General disorders
Pyrexia
|
21.2%
17/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
27.7%
31/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
3/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
2.7%
3/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Rhinitis
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
6.2%
7/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
4/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
6.2%
7/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
12/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
24.1%
27/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
50.0%
2/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Vessel puncture site cellulitis
|
0.00%
0/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
33.3%
1/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Infections and infestations
Viral infection
|
3.8%
3/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
10.7%
12/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
5/80 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
5.4%
6/112 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
25.0%
1/4 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
0.00%
0/3 • Up to approximately 9 years
SAS:participants in enrolled population with at least 1 BAX 855 infusion.IAS:participants who received at least 1 FVIII inhibitor treatment with BAX 855 during study after participant moved to FVIII inhibitor treatment.Participant that received on-demand treatment 1st and then moved to prophylaxis treatment was counted for both on-demand \& prophylaxis regimens and those who started with prophylaxis treatment was counted only for the prophylaxis regimen even if they received on-demand treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place