Trial Outcomes & Findings for Prophylaxis Regimen for Hemophilia A Patients (NCT NCT05036278)
NCT ID: NCT05036278
Last Updated: 2025-11-12
Results Overview
Overall number of participants with favorable outcomes after prophylaxis regimen assignment by a risk score, based on a participant's baseline phenotypic and biologic variables, when switching from a standard half-life (SHL) product to Jivi.
COMPLETED
PHASE4
21 participants
up to 6 months
2025-11-12
Participant Flow
The study was conducted at 14 study centers in the US between 28 July 2022 (first particpant first visit) and 12 September 2024 (last participant last visit).
A total of 21 participants were enrolled. 21 participants were assigned to treatment.
Participant milestones
| Measure |
Overall Study
2x/week (40 IU/kg/dose) with Jivi for 4 weeks, continued according to assigned prophylaxis regimen.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Overall Study
2x/week (40 IU/kg/dose) with Jivi for 4 weeks, continued according to assigned prophylaxis regimen.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Prophylaxis Regimen for Hemophilia A Patients
Baseline characteristics by cohort
| Measure |
Overall
n=21 Participants
2x/week (40 IU/kg/dose) with Jivi for 4 weeks, continued according to assigned prophylaxis regimen.
|
|---|---|
|
Age, Customized
Adolescents (12-17 years)
|
3 Participants
n=10 Participants
|
|
Age, Customized
Adults (18-64 years)
|
17 Participants
n=10 Participants
|
|
Age, Customized
From 65-84 years
|
1 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: all patients enrolled, followed for at least 4 months and not having switched from the prophylaxis regimen, determined by the risk-score; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
Overall number of participants with favorable outcomes after prophylaxis regimen assignment by a risk score, based on a participant's baseline phenotypic and biologic variables, when switching from a standard half-life (SHL) product to Jivi.
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=17 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Overall Number of Participants With Favorable Outcome on the Score-assigned Prophylaxis Regimen
|
12 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: all patients enrolled, followed for at least 4 months and not having switched from the prophylaxis regimen, determined by the risk-score; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess the efficacy of Jivi
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=17 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Annualized Bleeding Rate (ABR) (Total, Joint, Spontaneous)
total bleeds
|
4.172 bleeds per year
Standard Deviation 5.516
|
|
Annualized Bleeding Rate (ABR) (Total, Joint, Spontaneous)
joint bleeds
|
2.800 bleeds per year
Standard Deviation 4.160
|
|
Annualized Bleeding Rate (ABR) (Total, Joint, Spontaneous)
spontaneous bleeds
|
1.788 bleeds per year
Standard Deviation 3.968
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: all patients enrolled, followed for at least 4 months and not having switched from the prophylaxis regimen, determined by the risk-score; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess the efficacy of Jivi compared to a previous SHL treatment.
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=17 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Change in Total ABR From Pre-study
|
-8.005 bleeds per year
Standard Deviation 15.242
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: all patients enrolled, followed for at least 4 months; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess the frequency of Jivi administration.
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=17 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Change in the Frequency of Pre-study SHL Teratment to the Frequency of Jivi Administration (Infusions/Month)
|
-6.876 infusions per month
Standard Deviation 4.7557
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess the proportion of participants with 0 and ≤ 1 spontaneous bleeds.
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=19 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Occurrence of Participants With 0 and ≤ 1 Spontaneous Bleeds
<=1 spontaneous bleeds
|
13 participants
|
|
Occurrence of Participants With 0 and ≤ 1 Spontaneous Bleeds
0 spontaneous bleed
|
13 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months, only 10 participants completed this patient-reported outcome; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess participant quality of life (QoL) and physical activity, as measured by the Patient Reported Outcomes (PROs) Hemophilia A-specific quality of life and Hemophilia-specific quality of life. This includes 41 items covering 6 domains: Physical Functioning, Role Functioning, Worry, Consequences of Bleeding, Emotional Impact, and Treatment Concerns. The Haemo-QoL Short Form contains 35 items covering 9 domains: Physical Health, View of Yourself, Family, Friends, Others, Sports, Dealing, and Treatment. A higher score on the questionnaire represents greater impairment, and a negative change from baseline represents improvement. The percentage score is sum of item scores divided by the possible range. Individual item scores range from 1 to 5.
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=19 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Change in Haemophilia Quality of Life Questionnaire (Haem-A-QoL or Haemo-QoL)
Visit 2 (Baseline)
|
31.5 Percentage of scores on a scale
Standard Deviation 16.38
|
|
Change in Haemophilia Quality of Life Questionnaire (Haem-A-QoL or Haemo-QoL)
Change from baseline at visit 6
|
-4.7 Percentage of scores on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months, only 9 participants completed this patient-reported outcome; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess participant quality of life (QoL) and physical activity, as measured by Patient-Reported Outcomes (PROs).
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=9 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Patient's Global Impression of Change (PGI-C)
status much improved
|
2 Participants
|
|
Patient's Global Impression of Change (PGI-C)
status not changed
|
4 Participants
|
|
Patient's Global Impression of Change (PGI-C)
status very much improved
|
1 Participants
|
|
Patient's Global Impression of Change (PGI-C)
status minimally improved
|
1 Participants
|
|
Patient's Global Impression of Change (PGI-C)
status minimally worse
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months, only 11 participants completed this patient-reported outcome; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess participant quality of life (QoL) and physical activity, as measured by Patient-Reported Outcomes (PROs). Change to baseline means changes between Visit 2 and Visit 6
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=11 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
walking · improved, less impaired
|
1 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
walking · no change
|
5 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
walking · worsened, more impaired
|
5 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
self-care · improved, less impaired
|
1 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
self-care · no change
|
10 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
self-care · worsened, more impaired
|
0 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
usual activity · improved, less impaired
|
0 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
usual activity · no change
|
11 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
usual activity · worsened, more impaired
|
0 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
pain or discomfort · improved, less impaired
|
0 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
pain or discomfort · no change
|
9 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
pain or discomfort · worsened, more impaired
|
2 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
anxious or depressed · improved, less impaired
|
2 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
anxious or depressed · no change
|
6 Participants
|
|
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
anxious or depressed · worsened, more impaired
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months, only 5 participants completed this patient-reported outcome; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess participant quality of life (QoL) and physical activity, as measured by Patient-Reported Outcomes (PROs). Score ranges from 10 (lowest satisfaction) to 100 (greatest satisfaction).
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=5 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Visit 2 (baseline)
|
37.9 Percentage
Standard Deviation 7.44
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Change from baseline at visit 6
|
-1.8 Percentage
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months, participants' number completing this patient-reported outcome varied depending on parameter;This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
Work Productivity and Activity Impairment Questionnaire scores for hemophilia effect over the last 7 days on productivity or ability at work, at school, and in regular daily activities. It ranges from 0% to 100%, where higher scores indicate greater work impairment and less productivity. To assess participant quality of life (QoL) and physical activity, as measured by Patient Reported Outcomes (PROs). Baseline = Visit 2, Change from Baseline = Visit 6
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=19 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Work Time Missed (baseline) 7 participants
|
1.8 Percentage
Standard Deviation 4.64
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Work Time Missed (change from baseline) 4 participants
|
19.4 Percentage
Standard Deviation 24.21
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Working Impairment (baseline) 6 participants
|
26.7 Percentage
Standard Deviation 22.51
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Working Impairment (change from baseline) 3 participants
|
10.0 Percentage
Standard Deviation 20.00
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Class Time Missed (baseline) 4 participants
|
5.0 Percentage
Standard Deviation 10.00
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Class Time Missed (change from baseline) 2 participants
|
1.4 Percentage
Standard Deviation 1.96
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Class Attending Impairment (baseline) 4 participants
|
15.0 Percentage
Standard Deviation 19.15
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Class Attending Impairment (change) 2 participants
|
0 Percentage
Standard Deviation 28.28
|
|
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Percent Daily Activities Impairment (baseline) 12 participants
|
33.3 Percentage
Standard Deviation 29.34
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: All participants enrolled and followed for at least 4 months; This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
To assess target joint status, per modified International Society on Thrombosis and Haemostasis (ISTH) guidelines
Outcome measures
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=19 Participants
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Number of Target Joints and Change in Target Joint Status From Baseline
minus four (change from baseline)
|
1 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
minus two (change from baseline)
|
2 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
minus one (change from baseline)
|
4 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
zero (change from baseline)
|
8 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
zero (baseline)
|
8 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
one (baseline)
|
4 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
two (baseline)
|
2 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
three (baseline)
|
3 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
four (baseline)
|
2 Joints
|
|
Number of Target Joints and Change in Target Joint Status From Baseline
minus three (change from baseline)
|
4 Joints
|
Adverse Events
Damoctocog Alfa-pegol Prophylaxis Regimens
Serious adverse events
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=21 participants at risk
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Haemorrhage
|
9.5%
2/21 • Number of events 2 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
Other adverse events
| Measure |
Damoctocog Alfa-pegol Prophylaxis Regimens
n=21 participants at risk
Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (\> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (\< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Nervous system disorders
Taste disorder
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Infections and infestations
Staphylococcal infection
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Infections and infestations
Pharyngitis streptococcal
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
General disorders
Peripheral swelling
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
General disorders
Injection site bruising
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • All Adverse events were collected from the first study intervention up to 14 days after the end of study intervention, an average of 7 months.
Treatment Emergent AEs for Safety Population, i.e. all participants who have received at least one study intervention. This analysis included only one single arm. Within this single arm, each participant was assigned a prophylaxis regimen according to a risk score, based on a participant's phenotypic and biologic variables.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigative Site/Institution/ Principal Investigator have the right to publish the results of their activities only in accordance with the agreement and if they do not constitute a violation of the Confidential Information. They agree to submit any proposed publication to Sponsor for review. The sponsor has the right to require removal of specifically identified Confidential Information and/or to delay the proposed Publication for an additional 30-60 days.
- Publication restrictions are in place
Restriction type: OTHER