Trial Outcomes & Findings for Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour (NCT NCT03425253)
NCT ID: NCT03425253
Last Updated: 2020-12-31
Results Overview
The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Baseline (Day 0) to Week 58
Results posted on
2020-12-31
Participant Flow
Participants participated in the study at 3 study sites in Australia from 02 February 2018 to 05 December 2019.
Participant milestones
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Overall Study
STARTED
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58
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Overall Study
Safety Analysis Set
|
53
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Overall Study
FAS
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53
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Overall Study
Evaluable Set (ES)
|
42
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Overall Study
COMPLETED
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42
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Overall Study
NOT COMPLETED
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16
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Reasons for withdrawal
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Lost to Follow-up
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3
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Overall Study
Withdrew Consent
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6
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Overall Study
Did not Meet all Eligibility Criteria Defined in the Protocol
|
5
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Baseline Characteristics
Sequential Treatment With BELKYRA® Then Juvéderm® VOLUMA™ With Lidocaine for Overall Improvement in Jawline Contour
Baseline characteristics by cohort
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=53 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Age, Continuous
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48.0 years
STANDARD_DEVIATION 11.07 • n=5 Participants
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Sex: Female, Male
Female
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44 Participants
n=5 Participants
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Sex: Female, Male
Male
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9 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · White/Caucasian
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51 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Asian /Oriental
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Other
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: Evaluable Set (ES) included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The ALJDS was an investigator assessment of loss of jawline definition measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. Data is reported for both sides of the face, right side of the face and left side of the face.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
Right Side of the Face
|
92.9 percentage of participants
Interval 80.5 to 98.5
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Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
Both Sides of the Face
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92.9 percentage of participants
Interval 80.5 to 98.5
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Percentage of Participants Who Showed ≥ 1-point Jawline Improvement From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS), as Assessed by the Investigator
Left Side of the Face
|
92.9 percentage of participants
Interval 80.5 to 98.5
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Last Treatment (Up to Week 48)Population: FAS included all participants who received BELKYRA®. Number analyzed is the number of participants with available data at the given timepoint.
The ALJDS was an investigator and independent reviewer assessment of jawline contour measured by a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicated improvement. The data is reported for both sides of the face, right side of the face and left side of the face.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=53 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Investigator: Both Sides of Face, Baseline
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2.7 score on a scale
Standard Deviation 0.52
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Investigator: Both Sides of Face, Last Treatment
|
-0.6 score on a scale
Standard Deviation 0.71
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Investigator: Right Side of Face, Baseline
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2.5 score on a scale
Standard Deviation 0.50
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Investigator: Right Side of Face, Last Treatment
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-0.6 score on a scale
Standard Deviation 0.62
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Investigator: Left Side of Face, Baseline
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2.6 score on a scale
Standard Deviation 0.52
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Investigator: Left Side of Face, Last Treatment
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-0.6 score on a scale
Standard Deviation 0.72
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Independent Reviewer: Both Sides of Face, Baseline
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2.9 score on a scale
Standard Deviation 1.04
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Independent Reviewer: Both Sides of Face, Last Treatment
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-0.3 score on a scale
Standard Deviation 0.98
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Independent Reviewer: Right Side of Face, Baseline
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2.7 score on a scale
Standard Deviation 1.10
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Independent Reviewer: Right Side of Face, Last Treatment
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-0.1 score on a scale
Standard Deviation 1.13
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Independent Reviewer: Left Side of Face, Baseline
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2.7 score on a scale
Standard Deviation 1.03
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Mean Change From Baseline to Last BELKYRA® Treatment on the ALJDS
Independent Reviewer: Left Side of Face, Last Treatment
|
-0.4 score on a scale
Standard Deviation 1.01
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The participant assessed satisfaction using the 5 items on the Satisfaction of Lower Face and Jawline module of the FACE-Q™ questionnaire, measured on a 4-point scale where: 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
Baseline
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24.1 score on a score
Standard Deviation 16.78
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Mean Change From Baseline to Final Study Visit in the FACE-Q™ Satisfaction With Lower Face and Jawline Score
Change From Baseline to Week 58
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55.9 score on a score
Standard Deviation 21.78
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit. Overall number analyzed is the number of participants with available data at given timepoint.
The participant assessed satisfaction using the 10 items on the Appraisal of Neck module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A positive change from baseline indicated improvement.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=30 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
Baseline
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13.8 score on a scale
Standard Deviation 8.85
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Mean Change From Baseline to Final Study Visit in the FACE-Q™ Appraisal of Neck
Change From Baseline to Week 58
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-11.0 score on a scale
Standard Deviation 13.44
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The participant assessed satisfaction using the 5 items on the Appraisal of Area Under Chin module of the FACE-Q™ questionnaire measured on a 4-point scale where: 1=not at all, 2=a little, 3=moderately, 4=extremely. The Rasch transformed scale total score was 0 (worst) to 100 (best). A negative change from baseline indicated worsening.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
Baseline
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60.1 score on a scale
Standard Deviation 23.86
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Mean Change From Baseline to Final Study Visit for FACE-Q™ Appraisal of Area Under Chin
Change From Baseline to Week 58
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-45.4 score on a scale
Standard Deviation 17.09
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The CR-SMFRS score was based on the investigator's clinical evaluation of the participant, where submental fullness was scored on a 5-point scale where: 0=absent, 1=mild, 2=moderate, 3=severe, and 4=extreme. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Baseline
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2.5 score on a scale
Standard Deviation 0.50
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Mean Change From Baseline to Final Study Visit for Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Change From Baseline to Week 58
|
-1.9 score on a scale
Standard Deviation 0.67
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The PR-SMFRS was based on the participant's response to the question "How much fat do you have under your chin right now?" and answered on a 5-point ordinal scale where: 0=no chin fat at all, 1=a slight amount of chin fat, 2=a moderate amount of chin fat, 3=a large amount of chin fat, and 4=a very large amount of chin fat. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Change From Baseline to Week 58
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-1.6 score on a scale
Standard Deviation 0.61
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Mean Change From Baseline to Final Study Visit for Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Baseline
|
2.3 score on a scale
Standard Deviation 0.71
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The SMSLG scale integrated 3 skin features: skin wrinkling, adherence to underlying neck structures (bone and muscle), and redundancy (horizontal and vertical folds) assessed by the investigator using a 4-point scale where: 1=none, 2=mild, 3=moderate and 4=severe. A negative change from baseline indicated improvement.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
Baseline
|
2.0 score on a scale
Standard Deviation 0.62
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Mean Change From Baseline to Final Study Visit for Submental Skin Laxity Grade (SMSLG) Score
Change From Baseline to Week 58
|
-0.3 score on a scale
Standard Deviation 0.62
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SECONDARY outcome
Timeframe: Baseline (Day 0) to Week 58Population: ES included participants who received both study treatments (i.e., both BELKYRA® and VOLUMA™) and had a post-treatment efficacy assessment at the Exit Visit.
The independent reviewer used photographic images collected at the time of the participant's live visit and the ALJDS to assess of loss of jawline definition using a 5-point scale where: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=42 Participants
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Both Side of the Face, Baseline
|
2.9 score on a scale
Standard Deviation 1.05
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Both Side of the Face, End of Study
|
-0.7 score on a scale
Standard Deviation 0.91
|
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Right Side of the Face, Baseline
|
2.7 score on a scale
Standard Deviation 1.12
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Right Side of the Face, End of study
|
-0.5 score on a scale
Standard Deviation 0.98
|
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Left Side of the Face, Baseline
|
2.8 score on a scale
Standard Deviation 1.08
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Mean Change From Baseline to Final Study Visit in Jawline Definition, Based on Independent Reviewer Assessment Using the ALJDS and Photographic Images
Left Side of the Face, End of Study
|
-0.9 score on a scale
Standard Deviation 0.98
|
Adverse Events
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=53 participants at risk
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
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Gastrointestinal disorders
Volvulus
|
1.9%
1/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
1/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.9%
1/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
1/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
Other adverse events
| Measure |
BELKYRA® and Juvéderm® VOLUMA™ With Lidocaine
n=53 participants at risk
BELKYRA® was injected into subcutaneous preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart). When the investigator and participant agreed that no further intervention was required to achieve the desired result, participants were eligible to receive VOLUMA™ treatment. VOLUMA™ was injected along the mandibular border, with an optional touch-up visit 2 weeks later if applicable.
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|---|---|
|
Gastrointestinal disorders
Nausea
|
11.3%
6/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Influenza like illness
|
5.7%
3/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site discolouration
|
13.2%
7/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site discomfort
|
17.0%
9/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site erythema
|
20.8%
11/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site hypoaesthesia
|
54.7%
29/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site induration
|
45.3%
24/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site mass
|
58.5%
31/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site pain
|
73.6%
39/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site pruritus
|
9.4%
5/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site reaction
|
20.8%
11/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site swelling
|
73.6%
39/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site warmth
|
15.1%
8/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Swelling
|
7.5%
4/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
General disorders
Injection site bruising
|
71.7%
38/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Immune system disorders
Seasonal allergy
|
7.5%
4/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.5%
4/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.8%
11/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Investigations
Weight decreased
|
9.4%
5/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
3/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Nervous system disorders
Headache
|
24.5%
13/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
18.9%
10/53 • Up to Week 58
Safety Analysis Set included participants who are defined as Full Analysis Set (FAS) participants and those participants who underwent biopsy procedure but did not receive the BELKYRA® treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER