Trial Outcomes & Findings for A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects (NCT NCT02536833)
NCT ID: NCT02536833
Last Updated: 2021-03-17
Results Overview
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
COMPLETED
PHASE2
455 participants
Baseline and Week 13
2021-03-17
Participant Flow
Participant milestones
| Measure |
0.03 mg SM04690
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
112
|
117
|
110
|
116
|
|
Overall Study
COMPLETED
|
103
|
107
|
95
|
97
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
15
|
19
|
Reasons for withdrawal
| Measure |
0.03 mg SM04690
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Overall Study
Discontinued Before Treatment
|
0
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
3
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Site Terminated by Sponsor
|
2
|
2
|
2
|
2
|
|
Overall Study
Subject Non-Compliance
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
5
|
11
|
Baseline Characteristics
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
Baseline characteristics by cohort
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 9 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
60.3 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
268 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
187 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
374 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
392 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Kellgren-Lawrence Grade
Grade 2
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
|
Kellgren-Lawrence Grade
Grade 3
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
292 Participants
n=21 Participants
|
|
Kellgren-Lawrence Grade
Grade 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 13Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline Osteoarthritis (OA) Pain in the Target Knee
|
-23.3 score on a scale
Standard Error 2.2
|
-23.5 score on a scale
Standard Error 2.1
|
-21.3 score on a scale
Standard Error 2.2
|
-22.1 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline and Week 26Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Pain in the Target Knee
|
-24.7 score on a scale
Standard Error 2.3
|
-27.3 score on a scale
Standard Error 2.0
|
-23.3 score on a scale
Standard Error 2.1
|
-24.4 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline and Week 13Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Function in the Target Knee
|
-24.5 score on a scale
Standard Error 2.1
|
-26.3 score on a scale
Standard Error 2.0
|
-22.6 score on a scale
Standard Error 2.1
|
-22.8 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline and Week 26Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Function in the Target Knee
|
-25.1 score on a scale
Standard Error 2.2
|
-28.6 score on a scale
Standard Error 2.0
|
-24.1 score on a scale
Standard Error 2.0
|
-25.1 score on a scale
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Baseline and Week 13Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 13. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by the Patient
|
-18.1 mm
Standard Error 2.3
|
-13.7 mm
Standard Error 2.3
|
-14.6 mm
Standard Error 2.6
|
-14.0 mm
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Baseline and Week 26Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 26. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by the Patient
|
-21.3 score on a scale
Standard Error 2.4
|
-17.5 score on a scale
Standard Error 2.3
|
-17.2 score on a scale
Standard Error 2.6
|
-16.6 score on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline and Week 26Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 26.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline in Medial Joint Space Width of Target Knee
|
-0.07 mm
Standard Error 0.06
|
-0.11 mm
Standard Error 0.08
|
-0.02 mm
Standard Error 0.06
|
-0.20 mm
Standard Error 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Pain in the Target Knee
|
-24.7 score on a scale
Standard Error 2.5
|
-29.0 score on a scale
Standard Error 2.1
|
-25.5 score on a scale
Standard Error 2.1
|
-26.7 score on a scale
Standard Error 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Function in the Target Knee
|
-24.1 score on a scale
Standard Error 2.5
|
-29.6 score on a scale
Standard Error 2.0
|
-24.9 score on a scale
Standard Error 2.1
|
-25.1 score on a scale
Standard Error 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52.
Outcome measures
| Measure |
0.03 mg SM04690
n=112 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=117 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=110 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=116 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline in Medial Joint Space Width of Target Knee
|
-0.04 mm
Standard Error 0.06
|
-0.09 mm
Standard Error 0.06
|
-0.16 mm
Standard Error 0.07
|
-0.14 mm
Standard Error 0.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Population: Subjects with unilateral symptomatic OA in the ITT Analysis Set.
Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=45 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=35 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=45 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=39 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Pain in the Target Knee [Unilateral Symptomatic OA]
|
-28.6 score on a scale
Standard Error 3.5
|
-30.1 score on a scale
Standard Error 3.2
|
-26.6 score on a scale
Standard Error 3.1
|
-23.8 score on a scale
Standard Error 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Population: Subjects with unilateral symptomatic OA in the ITT Analysis Set.
Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals 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 a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Outcome measures
| Measure |
0.03 mg SM04690
n=45 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=35 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=45 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=39 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline OA Function in the Target Knee [Unilateral Symptomatic OA]
|
-29.0 score on a scale
Standard Error 3.9
|
-29.9 score on a scale
Standard Error 3.4
|
-25.6 score on a scale
Standard Error 3.1
|
-21.5 score on a scale
Standard Error 3.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 52Population: Subjects with unilateral symptomatic OA in the ITT Analysis Set.
Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52.
Outcome measures
| Measure |
0.03 mg SM04690
n=45 Participants
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=35 Participants
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=45 Participants
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=39 Participants
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
|---|---|---|---|---|
|
Change From Baseline in Medial Joint Space Width of Target Knee [Unilateral Symptomatic OA]
|
0.03 mm
Standard Error 0.10
|
0.19 mm
Standard Error 0.12
|
-0.22 mm
Standard Error 0.11
|
-0.21 mm
Standard Error 0.12
|
Adverse Events
0.03 mg SM04690
0.07 mg SM04690
0.23 mg SM04690
Placebo
Other
Serious adverse events
| Measure |
0.03 mg SM04690
n=111 participants at risk
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=114 participants at risk
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=104 participants at risk
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=108 participants at risk
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
Other
n=15 participants at risk
Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Cellulitis
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Diverticulitis
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Influenza
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.93%
1/108 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.93%
1/108 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Nervous system disorders
Myelitis transverse
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.93%
1/108 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/15 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
Other adverse events
| Measure |
0.03 mg SM04690
n=111 participants at risk
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
|
0.07 mg SM04690
n=114 participants at risk
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
|
0.23 mg SM04690
n=104 participants at risk
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
|
Placebo
n=108 participants at risk
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
|
Other
n=15 participants at risk
Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
General disorders
Oedema
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
4/111 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
2.6%
3/114 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
2.9%
3/104 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
5/111 • Number of events 5 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
1.8%
2/114 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
2.8%
3/108 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.8%
2/111 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.93%
1/108 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
13.3%
2/15 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.8%
2/111 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
1.8%
2/114 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.93%
1/108 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.93%
1/108 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
13/111 • Number of events 16 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
11.4%
13/114 • Number of events 14 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
8.7%
9/104 • Number of events 13 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
9.3%
10/108 • Number of events 12 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
26.7%
4/15 • Number of events 6 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.90%
1/111 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Nervous system disorders
Decreased vibratory sense
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
2.6%
3/114 • Number of events 6 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
1.9%
2/104 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
3.7%
4/108 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/111 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
0.00%
0/108 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
6.7%
1/15 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
|
Additional Information
Christopher Swearingen, PhD, VP of Clinical Outcomes and Analytics
Samumed
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place