Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee (NCT NCT04129944)
NCT ID: NCT04129944
Last Updated: 2021-12-29
Results Overview
WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2021-12-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
46
|
46
|
|
Overall Study
COMPLETED
|
44
|
45
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.0 years
n=5 Participants
|
63.0 years
n=7 Participants
|
66.0 years
n=5 Participants
|
63.0 years
n=4 Participants
|
64.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Missing data for some subjects.
WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale (WOMAC-A) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Change in Score from Baseline to Week 12
|
-1.07 score on a scale
Standard Deviation 0.924
|
-0.89 score on a scale
Standard Deviation 0.678
|
-1.03 score on a scale
Standard Deviation 0.884
|
-1.03 score on a scale
Standard Deviation 0.747
|
|
Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale (WOMAC-A) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Baseline
|
2.20 score on a scale
Standard Deviation 0.577
|
2.05 score on a scale
Standard Deviation 0.509
|
2.08 score on a scale
Standard Deviation 0.658
|
2.11 score on a scale
Standard Deviation 0.647
|
|
Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale (WOMAC-A) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Week 12
|
1.12 score on a scale
Standard Deviation 0.848
|
1.16 score on a scale
Standard Deviation 0.731
|
1.04 score on a scale
Standard Deviation 0.718
|
1.10 score on a scale
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Missing data for some subjects.
WOMAC-C is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of physical disability
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Function Subscale (WOMAC-C) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Week 12
|
1.18 score on a scale
Standard Deviation 0.812
|
1.11 score on a scale
Standard Deviation 0.771
|
1.17 score on a scale
Standard Deviation 0.772
|
1.24 score on a scale
Standard Deviation 0.827
|
|
Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Function Subscale (WOMAC-C) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Change in Score from Baseline to Week 12
|
-1.07 score on a scale
Standard Deviation 0.892
|
-1.06 score on a scale
Standard Deviation 0.770
|
-0.99 score on a scale
Standard Deviation 0.878
|
-1.00 score on a scale
Standard Deviation 0.772
|
|
Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Function Subscale (WOMAC-C) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Baseline
|
2.26 score on a scale
Standard Deviation 0.546
|
2.17 score on a scale
Standard Deviation 0.527
|
2.16 score on a scale
Standard Deviation 0.541
|
2.22 score on a scale
Standard Deviation 0.660
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Missing data for some subjects.
ADP is assessed by NRS on a range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating higher levels of pain
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 of the Weekly Mean of the Average Daily Pain (ADP) Intensity Scores on the 11-point Numeric Rating Scale (NRS) in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Week 12
|
3.48 Score on a scale
Standard Deviation 2.597
|
3.51 Score on a scale
Standard Deviation 2.262
|
3.67 Score on a scale
Standard Deviation 2.217
|
3.95 Score on a scale
Standard Deviation 2.029
|
|
Change From Baseline to Week 12 of the Weekly Mean of the Average Daily Pain (ADP) Intensity Scores on the 11-point Numeric Rating Scale (NRS) in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Baseline
|
6.66 Score on a scale
Standard Deviation 1.382
|
6.48 Score on a scale
Standard Deviation 1.167
|
6.56 Score on a scale
Standard Deviation 1.463
|
6.68 Score on a scale
Standard Deviation 1.542
|
|
Change From Baseline to Week 12 of the Weekly Mean of the Average Daily Pain (ADP) Intensity Scores on the 11-point Numeric Rating Scale (NRS) in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo
Change in Score from Baseline to Week 12
|
-3.14 Score on a scale
Standard Deviation 2.626
|
-3.05 Score on a scale
Standard Deviation 2.155
|
-2.83 Score on a scale
Standard Deviation 2.452
|
-2.63 Score on a scale
Standard Deviation 2.041
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Missing data for some subjects.
WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain WOMAC-C is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of physical disability. Average Daily Pain (ADP) is assessed by Numerical Rating Score (NRS) on a range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating higher levels of pain.
Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
WOMAC-A Baseline
|
2.20 score on a scale
Standard Deviation 0.577
|
2.05 score on a scale
Standard Deviation 0.509
|
2.08 score on a scale
Standard Deviation 0.658
|
2.11 score on a scale
Standard Deviation 0.647
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
WOMAC-A Week 24
|
1.06 score on a scale
Standard Deviation 0.872
|
1.04 score on a scale
Standard Deviation 0.777
|
1.09 score on a scale
Standard Deviation 0.683
|
1.12 score on a scale
Standard Deviation 0.821
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
Change in WOMAC-A Score from Baseline to Week 24
|
-1.12 score on a scale
Standard Deviation 0.936
|
-1.02 score on a scale
Standard Deviation 0.711
|
-1.00 score on a scale
Standard Deviation 0.735
|
-1.00 score on a scale
Standard Deviation 0.884
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
WOMAC-C Baseline
|
2.26 score on a scale
Standard Deviation 0.546
|
2.17 score on a scale
Standard Deviation 0.527
|
2.16 score on a scale
Standard Deviation 0.541
|
2.22 score on a scale
Standard Deviation 0.660
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
WOMAC-C Week 24
|
1.14 score on a scale
Standard Deviation 0.853
|
1.03 score on a scale
Standard Deviation 0.803
|
1.17 score on a scale
Standard Deviation 0.714
|
1.22 score on a scale
Standard Deviation 0.848
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
Change in WOMAC-C Score from Baseline to Week 24
|
-1.11 score on a scale
Standard Deviation 0.902
|
-1.13 score on a scale
Standard Deviation 0.822
|
-1.01 score on a scale
Standard Deviation 0.736
|
-1.00 score on a scale
Standard Deviation 0.728
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
NRS Baseline
|
6.66 score on a scale
Standard Deviation 1.382
|
6.48 score on a scale
Standard Deviation 1.167
|
6.56 score on a scale
Standard Deviation 1.463
|
6.68 score on a scale
Standard Deviation 1.542
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
NRS Week 24
|
3.60 score on a scale
Standard Deviation 2.317
|
3.14 score on a scale
Standard Deviation 2.094
|
3.50 score on a scale
Standard Deviation 2.171
|
3.52 score on a scale
Standard Deviation 2.029
|
|
Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo
Change in NRS Score from Baseline to Week 24
|
-3.01 score on a scale
Standard Deviation 2.235
|
-3.26 score on a scale
Standard Deviation 2.139
|
-3.22 score on a scale
Standard Deviation 2.458
|
-2.91 score on a scale
Standard Deviation 2.412
|
SECONDARY outcome
Timeframe: Baseline to Week 24Outcome measures
| Measure |
Placebo
n=46 Participants
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 Participants
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
|
18 Participants
|
20 Participants
|
24 Participants
|
21 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
UBX0101 0.5 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
UBX0101 2.0 mg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
UBX0101 4.0 mg
Serious events: 3 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=46 participants at risk
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 participants at risk
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 participants at risk
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 participants at risk
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Endocrine disorders
Goitre
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Placebo: Placebo intra-articular injection
|
UBX0101 0.5 mg
n=45 participants at risk
UBX0101: Investigational drug intra-articular injection
|
UBX0101 2.0 mg
n=46 participants at risk
UBX0101: Investigational drug intra-articular injection
|
UBX0101 4.0 mg
n=46 participants at risk
UBX0101: Investigational drug intra-articular injection
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Endocrine disorders
Goitre
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Chest Discomfort
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Chest Pain
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Discomfort
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Injection Site Erythema
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Injection Site Irritation
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Injection Site Pruritus
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Oedema Peripheral
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Pain
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Chronic Sinusitis
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Covid-19
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Ear Infection
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
6.5%
3/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Periorbital Cellulitis
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Upper Respiratory Tract InfectionUpper Respiratory Tract Infection
|
6.5%
3/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
8.7%
4/46 • 24 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
6.5%
3/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
2/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.2%
1/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
2.2%
1/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Discomfort
|
2.2%
1/46 • 24 weeks
|
4.4%
2/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Inflammation
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Post Procedural Swelling
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.2%
1/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
15.2%
7/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
4/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
8.7%
4/46 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Laxity
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Noise
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.3%
2/46 • 24 weeks
|
4.4%
2/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip Neoplasm
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
2.2%
1/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
4.3%
2/46 • 24 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Nervous system disorders
Lumbar Radiculopathu
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Social circumstances
Menopause
|
0.00%
0/46 • 24 weeks
|
2.2%
1/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Social circumstances
Walking Aid User
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/46 • 24 weeks
|
0.00%
0/45 • 24 weeks
|
2.2%
1/46 • 24 weeks
|
0.00%
0/46 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of Study results will not be made before the first multi-site publication by Sponsor. If no manuscript is submitted within 12 months after the Study's database lock, Investigator may publish Study results if he/she submits all proposed Publications to Sponsor 60 days prior to submission. Investigator shall delete Sponsor's Confidential Information and delay Publication up to 60 days to allow Sponsor to file a patent on Confidential Information in the Publication.
- Publication restrictions are in place
Restriction type: OTHER