Trial Outcomes & Findings for Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (NCT NCT03928184)
NCT ID: NCT03928184
Last Updated: 2026-02-13
Results Overview
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain numeric rating scale (NRS). The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
501 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2026-02-13
Participant Flow
Participant milestones
| Measure |
0.07 mg Lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
248
|
253
|
|
Overall Study
Safety Analysis Set
|
249
|
252
|
|
Overall Study
COMPLETED
|
224
|
223
|
|
Overall Study
NOT COMPLETED
|
24
|
30
|
Reasons for withdrawal
| Measure |
0.07 mg Lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
10
|
|
Overall Study
Subject Non-Compliance
|
1
|
0
|
|
Overall Study
Total or Partial Knee Replacement of the Target Knee
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
16
|
Baseline Characteristics
Patient-Reported and Radiographic Outcomes in Evaluating Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
0.07 mg Lorecivivint
n=248 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=253 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Total
n=501 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 8.0 • n=41 Participants
|
61.0 years
STANDARD_DEVIATION 8.7 • n=1581 Participants
|
60.9 years
STANDARD_DEVIATION 8.3 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=41 Participants
|
163 Participants
n=1581 Participants
|
328 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=41 Participants
|
90 Participants
n=1581 Participants
|
173 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=41 Participants
|
54 Participants
n=1581 Participants
|
100 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=41 Participants
|
199 Participants
n=1581 Participants
|
401 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=41 Participants
|
65 Participants
n=1581 Participants
|
131 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
171 Participants
n=41 Participants
|
175 Participants
n=1581 Participants
|
346 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Kellgren-Lawrence Grade
Grade 2
|
124 Participants
n=41 Participants
|
134 Participants
n=1581 Participants
|
258 Participants
n=4626 Participants
|
|
Kellgren-Lawrence Grade
Grade 3
|
124 Participants
n=41 Participants
|
119 Participants
n=1581 Participants
|
243 Participants
n=4626 Participants
|
|
Osteoarthritis Symptoms Laterality
Bilateral
|
168 Participants
n=41 Participants
|
171 Participants
n=1581 Participants
|
339 Participants
n=4626 Participants
|
|
Osteoarthritis Symptoms Laterality
Unilateral
|
80 Participants
n=41 Participants
|
82 Participants
n=1581 Participants
|
162 Participants
n=4626 Participants
|
|
Medial Joint Space Width
|
2.61 mm
STANDARD_DEVIATION 0.74 • n=41 Participants
|
2.61 mm
STANDARD_DEVIATION 0.69 • n=1581 Participants
|
2.61 mm
STANDARD_DEVIATION 0.72 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain numeric rating scale (NRS). The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=221 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=225 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Pain in the Target Knee (Pain NRS)
|
-2.24 units on a scale
Standard Error 0.13
|
-2.49 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=210 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=212 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Pain in the Target Knee (Pain NRS)
|
-2.42 units on a scale
Standard Error 0.14
|
-2.56 units on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=195 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=192 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Pain in the Target Knee (Pain NRS)
|
-2.31 units on a scale
Standard Error 0.14
|
-2.47 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=239 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=236 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Function in the Target Knee (WOMAC Function)
|
-21.87 units on a scale
Standard Error 1.34
|
-23.67 units on a scale
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=228 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=231 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Function in the Target Knee (WOMAC Function)
|
-23.07 units on a scale
Standard Error 1.42
|
-23.93 units on a scale
Standard Error 1.41
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on an 11-point numeric rating scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function raw subscore ranges from 0 to 170, and is scaled 0 (highest overall function) to 100 (lowest overall function) for analysis and reporting.
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=219 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=215 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Function in the Target Knee (WOMAC Function)
|
-22.08 units on a scale
Standard Error 1.48
|
-22.95 units on a scale
Standard Error 1.48
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=238 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=235 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Disease Activity (Patient Global Assessment)
|
-25.26 units on a scale
Standard Error 1.45
|
-25.89 units on a scale
Standard Error 1.45
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=228 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=231 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Disease Activity (Patient Global Assessment)
|
-25.41 units on a scale
Standard Error 1.50
|
-26.31 units on a scale
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline OA disease activity as assessed by Patient Global Assessment. The Patient Global Assessment is an 11-point \[0-10\] Numeric Rating Scale \[NRS\] on which the subjects will rate how they feel their target knee OA is doing, considering all the ways in which their target knee OA may affect them. The NRS is anchored by descriptors at each end ("Very Good" on the left and "Very Bad" on the right). For analysis, Patient Global Assessment scores were scaled to \[0-100\], where 0 represents "Very Good" and 100 represents "Very Bad".
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=218 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=215 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in OA Disease Activity (Patient Global Assessment)
|
-23.79 units on a scale
Standard Error 1.63
|
-24.76 units on a scale
Standard Error 1.63
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Population: Full Analysis Set includes all subjects who received a study injection. Subjects' observed data were analyzed as randomized for the FAS without imputation.
Evaluate change from baseline in mJSW as documented by radiograph of the target knee
Outcome measures
| Measure |
0.07 mg Lorecivivint
n=217 Participants
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=215 Participants
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Change From Baseline in Medial Joint Space Width (mJSW) in the Target Knee
|
-0.10 mm
Standard Error 0.03
|
-0.07 mm
Standard Error 0.03
|
Adverse Events
0.07 mg Lorecivivint
Serious events: 12 serious events
Other events: 85 other events
Deaths: 1 deaths
Vehicle
Serious events: 13 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.07 mg Lorecivivint
n=249 participants at risk
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=252 participants at risk
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.80%
2/249 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.80%
2/249 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Clostridium difficile infection
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Diverticulitis
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Endocarditis
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Salmonellosis
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Nervous system disorders
Sciatica
|
0.40%
1/249 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.00%
0/252 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.79%
2/252 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.79%
2/252 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Injury, poisoning and procedural complications
Influenza
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Sepsis
|
0.00%
0/249 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
Other adverse events
| Measure |
0.07 mg Lorecivivint
n=249 participants at risk
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle
Lorecivivint: Healthcare professional-administered intra-articular injection; performed on Day 1
|
Vehicle
n=252 participants at risk
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle
Placebo: Healthcare professional-administered intra-articular injection; performed on Day 1
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.6%
19/249 • Number of events 21 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
6.7%
17/252 • Number of events 19 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
16/249 • Number of events 17 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
5.2%
13/252 • Number of events 13 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
13/249 • Number of events 14 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
3.2%
8/252 • Number of events 10 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
COVID-19
|
4.4%
11/249 • Number of events 11 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.8%
7/252 • Number of events 7 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.8%
7/249 • Number of events 8 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
1.6%
4/252 • Number of events 4 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
7/249 • Number of events 7 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
1.6%
4/252 • Number of events 6 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Nervous system disorders
Headache
|
2.4%
6/249 • Number of events 11 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
4.0%
10/252 • Number of events 13 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
6/249 • Number of events 6 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.0%
5/252 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Nervous system disorders
Sciatica
|
2.0%
5/249 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.79%
2/252 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
5/249 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.0%
5/252 • Number of events 6 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
5/249 • Number of events 6 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.79%
2/252 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
5/249 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
0.40%
1/252 • Number of events 1 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Sinusitis
|
1.6%
4/249 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.4%
6/252 • Number of events 6 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Vascular disorders
Hypertension
|
1.2%
3/249 • Number of events 3 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
4.4%
11/252 • Number of events 12 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Gastrointestinal disorders
Toothache
|
1.2%
3/249 • Number of events 4 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.0%
5/252 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Infections and infestations
Bronchitis
|
0.80%
2/249 • Number of events 3 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.0%
5/252 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.80%
2/249 • Number of events 2 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
2.0%
5/252 • Number of events 5 • AEs were assessed at each in-person and phone visit from the time of study medication injection on Day 1 through Week 56 (EOS) or Early Termination.
Safety Analysis Set includes all subjects who received a study injection categorized as treated. One subject randomized to PLACEBO was mistakenly administered LORECIVIVINT instead, which accounts for the discrepancy of 1 between the treatment group sizes.
|
Additional Information
Christopher Swearingen, PhD, VP of Biometrics
Biosplice Therapeutics
Phone: 858.926.2900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER