Trial Outcomes & Findings for Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain (NCT NCT04123561)
NCT ID: NCT04123561
Last Updated: 2024-10-08
Results Overview
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2024-10-08
Participant Flow
Patients were screened for study eligibility at multiple study centers in the United States (US) and Australia.
Participant milestones
| Measure |
TLC599 12 mg
TLC599: 1 mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
DSP 4 mg
DSP 4 mg: 1 mL IA injection
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
|
Placebo
Normal saline: 1 mL IA injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
252
|
126
|
126
|
|
Overall Study
COMPLETED
|
208
|
96
|
101
|
|
Overall Study
NOT COMPLETED
|
44
|
30
|
25
|
Reasons for withdrawal
| Measure |
TLC599 12 mg
TLC599: 1 mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
DSP 4 mg
DSP 4 mg: 1 mL IA injection
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
|
Placebo
Normal saline: 1 mL IA injection
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
12
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
9
|
|
Overall Study
Lack of Efficacy
|
7
|
8
|
6
|
|
Overall Study
Adverse Event
|
5
|
2
|
3
|
|
Overall Study
A surgical procedure or IA administration in the index knee
|
3
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Baseline characteristics by cohort
| Measure |
TLC599 12 mg
n=252 Participants
TLC599:1 mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
DSP 4 mg
n=126 Participants
DSP 4mg:1 mL IA injection Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
|
Placebo
n=126 Participants
Normal saline: 1 mL IA injection
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
162 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
322 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 9.50 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 8.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
296 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
207 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
422 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
384 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Region of Enrollment
United States
|
224 participants
n=5 Participants
|
114 participants
n=7 Participants
|
109 participants
n=5 Participants
|
447 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
28 participants
n=5 Participants
|
12 participants
n=7 Participants
|
17 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Mean body mass index
|
31.13 kg/m^2
STANDARD_DEVIATION 4.772 • n=5 Participants
|
31.80 kg/m^2
STANDARD_DEVIATION 5.144 • n=7 Participants
|
31.33 kg/m^2
STANDARD_DEVIATION 4.603 • n=5 Participants
|
31.35 kg/m^2
STANDARD_DEVIATION 4.825 • n=4 Participants
|
|
Mean weight
|
89.30 Kg
STANDARD_DEVIATION 17.816 • n=5 Participants
|
91.71 Kg
STANDARD_DEVIATION 19.425 • n=7 Participants
|
89.55 Kg
STANDARD_DEVIATION 17.750 • n=5 Participants
|
89.96 Kg
STANDARD_DEVIATION 18.207 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo
|
-0.968 score on a scale
Interval -1.06 to -0.877
|
-0.798 score on a scale
Interval -0.93 to -0.665
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo
|
-0.929 score on a scale
Standard Error 0.0492
|
-0.798 score on a scale
Standard Error 0.0704
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo
|
-0.873 score on a scale
Standard Error 0.0489
|
-0.749 score on a scale
Standard Error 0.0703
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo
|
-0.845 score on a scale
Standard Error 0.0496
|
-0.688 score on a scale
Standard Error 0.0719
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo
|
-0.964 score on a scale
Standard Error 0.0545
|
-0.882 score on a scale
Standard Error 0.0791
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo
|
-0.903 score on a scale
Standard Error 0.0470
|
-0.735 score on a scale
Standard Error 0.0681
|
SECONDARY outcome
Timeframe: Week 12Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
PGIC at Week 12 for TLC599 12mg Versus Placebo
|
2.554 score on a scale
Standard Error 0.0739
|
2.791 score on a scale
Standard Error 0.1059
|
SECONDARY outcome
Timeframe: through Week 12Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
Rescue medication use of acetaminophen was provided and recorded in electronic patient diaries. Weekly Total Acetaminophen consumption was tabulated for analysis on a weekly basis, starting from the first date of study drug injection: (Day 1, 8), (Day 8, 15), and so on. Average daily use (e.g., Weekly Total Acetaminophen Consumption divided by 7) was computed to produce Weekly Average Daily Acetaminophen Consumption.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo
|
15.568 tablets per week
Standard Error 3.1902
|
29.803 tablets per week
Standard Error 4.5893
|
SECONDARY outcome
Timeframe: Weeks 4 through 12Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
Durable responder endpoints were derived based on the imputed WOMAC pain data. A subject which has ≥ 30% decrease in pain response from Baseline at each visit within a specified time period (x-y). This was derived for patients based on the Injection 1 Baseline for the following time period (x-y): (4-12).
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo
|
45.5 percentage of responder
|
39.0 percentage of responder
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo
|
-0.907 score on a scale
Standard Error 0.0540
|
-0.787 score on a scale
Standard Error 0.0774
|
SECONDARY outcome
Timeframe: Week 36Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
PGIC at Week 36 for TLC599 12mg Versus Placebo
|
2.635 score on a scale
Standard Error 0.0883
|
2.738 score on a scale
Standard Error 0.1288
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg
|
-0.968 score on a scale
Standard Error 0.0467
|
-0.933 score on a scale
Standard Error 0.0667
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.
The WOMAC (Western Ontario \& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.
Outcome measures
| Measure |
TLC599 12mg
n=252 Participants
TLC599 :1mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
Placebo
n=126 Participants
Normal saline: 1mL IA injection
|
|---|---|---|
|
Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo
|
-0.928 score on a scale
Standard Error 0.0580
|
-0.934 score on a scale
Standard Error 0.0820
|
Adverse Events
TLC599 12 mg
Serious events: 16 serious events
Other events: 73 other events
Deaths: 1 deaths
DSP 4 mg
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TLC599 12 mg
n=252 participants at risk
TLC599 :1 mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
DSP 4 mg
n=126 participants at risk
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
|
Placebo
n=126 participants at risk
Normal saline: 1 mL IA injection
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.6%
4/252 • Number of events 4 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
1.6%
2/126 • Number of events 2 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Infections and infestations
Septic shock
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Cardiac disorders
Cardiac arrest
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Gastrointestinal disorders
Hiatus hemia
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Injury, poisoning and procedural complications
extradural haematoma
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Nervous system disorders
syncope
|
0.40%
1/252 • Number of events 2 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.79%
2/252 • Number of events 2 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Hepatobiliary disorders
cholecystitis
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/252 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Investigations
Blood pressure increased
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.40%
1/252 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.00%
0/126 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
Other adverse events
| Measure |
TLC599 12 mg
n=252 participants at risk
TLC599 :1 mL IA injection
TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
|
DSP 4 mg
n=126 participants at risk
Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
|
Placebo
n=126 participants at risk
Normal saline: 1 mL IA injection
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
30/252 • Number of events 35 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
4.0%
5/126 • Number of events 5 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
7.9%
10/126 • Number of events 12 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
13/252 • Number of events 14 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
7.9%
10/126 • Number of events 10 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
0.79%
1/126 • Number of events 1 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Infections and infestations
COVID-19
|
4.8%
12/252 • Number of events 12 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
6.3%
8/126 • Number of events 8 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
2.4%
3/126 • Number of events 3 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
9/252 • Number of events 11 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
1.6%
2/126 • Number of events 2 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
5.6%
7/126 • Number of events 7 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
|
Vascular disorders
Hypertension
|
3.6%
9/252 • Number of events 10 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
6.3%
8/126 • Number of events 8 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
5.6%
7/126 • Number of events 8 • Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.
All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60