Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (NCT NCT03122860)
NCT ID: NCT03122860
Last Updated: 2021-06-11
Results Overview
Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
700 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2021-06-11
Participant Flow
The Full Analysis Set (FAS) includes all subjects who were randomized and received a study injection, analyzed as randomized.
The Safety Analysis Set (SAS) \[see 'Adverse Events' section\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between FAS and SAS is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
Participant milestones
| Measure |
0.03 mg SM04690
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
117
|
116
|
117
|
116
|
117
|
117
|
|
Overall Study
Full Analysis Set
|
116
|
115
|
115
|
116
|
116
|
117
|
|
Overall Study
COMPLETED
|
107
|
111
|
105
|
105
|
102
|
105
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
12
|
11
|
15
|
12
|
Reasons for withdrawal
| Measure |
0.03 mg SM04690
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Overall Study
Discontinued Before Treatment
|
1
|
1
|
2
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
3
|
3
|
5
|
4
|
|
Overall Study
Subject Non-Compliance
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
5
|
7
|
9
|
8
|
Baseline Characteristics
BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
Baseline characteristics by cohort
| Measure |
0.03 mg SM04690
n=116 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=115 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=115 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=116 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=116 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=117 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
Total
n=695 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 7.9 • n=116 Participants
|
59.9 years
STANDARD_DEVIATION 8.6 • n=115 Participants
|
58.4 years
STANDARD_DEVIATION 8.3 • n=115 Participants
|
58.5 years
STANDARD_DEVIATION 9.0 • n=116 Participants
|
60.1 years
STANDARD_DEVIATION 9.0 • n=116 Participants
|
59.0 years
STANDARD_DEVIATION 8.0 • n=117 Participants
|
59.0 years
STANDARD_DEVIATION 8.5 • n=695 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=116 Participants
|
66 Participants
n=115 Participants
|
69 Participants
n=115 Participants
|
61 Participants
n=116 Participants
|
64 Participants
n=116 Participants
|
70 Participants
n=117 Participants
|
406 Participants
n=695 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=116 Participants
|
49 Participants
n=115 Participants
|
46 Participants
n=115 Participants
|
55 Participants
n=116 Participants
|
52 Participants
n=116 Participants
|
47 Participants
n=117 Participants
|
289 Participants
n=695 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=116 Participants
|
22 Participants
n=115 Participants
|
22 Participants
n=115 Participants
|
10 Participants
n=116 Participants
|
16 Participants
n=116 Participants
|
24 Participants
n=117 Participants
|
115 Participants
n=695 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=116 Participants
|
93 Participants
n=115 Participants
|
93 Participants
n=115 Participants
|
106 Participants
n=116 Participants
|
100 Participants
n=116 Participants
|
93 Participants
n=117 Participants
|
580 Participants
n=695 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=116 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=695 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=116 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=116 Participants
|
2 Participants
n=116 Participants
|
2 Participants
n=117 Participants
|
6 Participants
n=695 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=116 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=116 Participants
|
6 Participants
n=116 Participants
|
3 Participants
n=117 Participants
|
30 Participants
n=695 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=116 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=116 Participants
|
2 Participants
n=117 Participants
|
6 Participants
n=695 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=116 Participants
|
22 Participants
n=115 Participants
|
25 Participants
n=115 Participants
|
21 Participants
n=116 Participants
|
17 Participants
n=116 Participants
|
24 Participants
n=117 Participants
|
133 Participants
n=695 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=116 Participants
|
83 Participants
n=115 Participants
|
84 Participants
n=115 Participants
|
89 Participants
n=116 Participants
|
90 Participants
n=116 Participants
|
86 Participants
n=117 Participants
|
517 Participants
n=695 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=116 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=117 Participants
|
3 Participants
n=695 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=116 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=695 Participants
|
|
Body Mass Index (BMI)
|
29.17 kg/m²
STANDARD_DEVIATION 3.76 • n=115 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
29.14 kg/m²
STANDARD_DEVIATION 3.64 • n=115 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
29.38 kg/m²
STANDARD_DEVIATION 4.10 • n=115 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
28.53 kg/m²
STANDARD_DEVIATION 4.39 • n=116 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
28.62 kg/m²
STANDARD_DEVIATION 4.29 • n=116 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
28.97 kg/m²
STANDARD_DEVIATION 3.84 • n=117 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
28.97 kg/m²
STANDARD_DEVIATION 4.01 • n=694 Participants • BMI was not collected for one participant in the 0.03 mg SM04690 cohort.
|
|
Kellgren-Lawrence Grade
Grade 1
|
0 Participants
n=116 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=117 Participants
|
1 Participants
n=695 Participants
|
|
Kellgren-Lawrence Grade
Grade 2
|
53 Participants
n=116 Participants
|
38 Participants
n=115 Participants
|
47 Participants
n=115 Participants
|
53 Participants
n=116 Participants
|
43 Participants
n=116 Participants
|
57 Participants
n=117 Participants
|
291 Participants
n=695 Participants
|
|
Kellgren-Lawrence Grade
Grade 3
|
63 Participants
n=116 Participants
|
74 Participants
n=115 Participants
|
68 Participants
n=115 Participants
|
63 Participants
n=116 Participants
|
72 Participants
n=116 Participants
|
58 Participants
n=117 Participants
|
398 Participants
n=695 Participants
|
|
Kellgren-Lawrence Grade
Grade 4
|
0 Participants
n=116 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=116 Participants
|
2 Participants
n=117 Participants
|
5 Participants
n=695 Participants
|
|
Osteoarthritis Laterality
Unilateral
|
59 Participants
n=116 Participants
|
62 Participants
n=115 Participants
|
63 Participants
n=115 Participants
|
63 Participants
n=116 Participants
|
61 Participants
n=116 Participants
|
62 Participants
n=117 Participants
|
370 Participants
n=695 Participants
|
|
Osteoarthritis Laterality
Bilateral
|
57 Participants
n=116 Participants
|
53 Participants
n=115 Participants
|
52 Participants
n=115 Participants
|
53 Participants
n=116 Participants
|
55 Participants
n=116 Participants
|
55 Participants
n=117 Participants
|
325 Participants
n=695 Participants
|
|
Widespread Pain (WP)
WP-
|
92 Participants
n=116 Participants
|
93 Participants
n=115 Participants
|
90 Participants
n=115 Participants
|
93 Participants
n=116 Participants
|
93 Participants
n=116 Participants
|
94 Participants
n=117 Participants
|
555 Participants
n=695 Participants
|
|
Widespread Pain (WP)
WP+
|
24 Participants
n=116 Participants
|
22 Participants
n=115 Participants
|
25 Participants
n=115 Participants
|
23 Participants
n=116 Participants
|
23 Participants
n=116 Participants
|
23 Participants
n=117 Participants
|
140 Participants
n=695 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).
Outcome measures
| Measure |
0.03 mg SM04690
n=98 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=102 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=92 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=90 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=95 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=91 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline Osteoarthritis (OA) Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS)
|
-2.77 score on a scale
Standard Deviation 2.44
|
-2.93 score on a scale
Standard Deviation 2.21
|
-2.43 score on a scale
Standard Deviation 2.18
|
-3.03 score on a scale
Standard Deviation 2.43
|
-2.26 score on a scale
Standard Deviation 2.44
|
-2.21 score on a scale
Standard Deviation 2.46
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 24. 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 standardized and reported ranging from 0 to 100 \[0 = no pain; 100 = pain as bad as it can be\].
Outcome measures
| Measure |
0.03 mg SM04690
n=94 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=102 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=93 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=93 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=93 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=92 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore (WOMAC Pain)
|
-27.6 score on a scale
Standard Error 22.8
|
-30.0 score on a scale
Standard Error 22.5
|
-24.7 score on a scale
Standard Error 21.6
|
-33.3 score on a scale
Standard Error 22.9
|
-25.5 score on a scale
Standard Error 25.8
|
-22.5 score on a scale
Standard Error 24.6
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 24. 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 standardized and reported ranging from 0 to 100 \[0 = no functional disability, 100 = unable to function\].
Outcome measures
| Measure |
0.03 mg SM04690
n=94 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=102 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=93 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=93 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=93 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=92 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)
|
-27.7 score on a scale
Standard Deviation 21.1
|
-29.3 score on a scale
Standard Deviation 23.0
|
-23.6 score on a scale
Standard Deviation 21.6
|
-32.4 score on a scale
Standard Deviation 22.1
|
-24.9 score on a scale
Standard Deviation 23.7
|
-23.8 score on a scale
Standard Deviation 23.7
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline in mJSW as documented by radiograph of the target knee.
Outcome measures
| Measure |
0.03 mg SM04690
n=104 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=109 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=103 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=101 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=96 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=104 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Medial Joint Space Width (mJSW) of the Target Knee
|
0.02 mm
Standard Deviation 0.72
|
-0.11 mm
Standard Deviation 0.53
|
-0.11 mm
Standard Deviation 0.92
|
-0.03 mm
Standard Deviation 0.45
|
-0.01 mm
Standard Deviation 0.60
|
-0.08 mm
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA disease activity as assessed by PtGA at Week 24. The PtGA 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=90 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=99 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=92 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=92 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=90 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=90 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)
|
-16.0 mm
Standard Deviation 23.5
|
-19.8 mm
Standard Deviation 27.1
|
-11.9 mm
Standard Deviation 27.5
|
-18.3 mm
Standard Deviation 24.5
|
-13.0 mm
Standard Deviation 21.6
|
-13.8 mm
Standard Deviation 24.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA pain in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 12. 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 standardized and reported ranging from 0 to 100 \[0 = no pain, 100 = pain as bad as it can be\].
Outcome measures
| Measure |
0.03 mg SM04690
n=103 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=98 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=100 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=101 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=101 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=106 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assessed by WOMAC Pain Subscore (WOMAC Pain)
|
-25.8 score on a scale
Standard Deviation 20.5
|
-29.3 score on a scale
Standard Deviation 21.5
|
-22.1 score on a scale
Standard Deviation 20.2
|
-32.1 score on a scale
Standard Deviation 21.2
|
-23.7 score on a scale
Standard Deviation 24.6
|
-22.8 score on a scale
Standard Deviation 23.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA function in the target knee as assessed by WOMAC Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 12. 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 standardized and reported ranging from 0 to 100 \[0 = no functional disability, 100 = unable to function\].
Outcome measures
| Measure |
0.03 mg SM04690
n=103 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=98 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=100 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=101 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=101 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=106 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Function in the Target Knee as Assessed by WOMAC Physical Function Subscore (WOMAC Function)
|
-26.0 score on a scale
Standard Deviation 19.0
|
-29.3 score on a scale
Standard Deviation 21.8
|
-20.9 score on a scale
Standard Deviation 20.2
|
-30.4 score on a scale
Standard Deviation 21.3
|
-22.7 score on a scale
Standard Deviation 23.2
|
-22.7 score on a scale
Standard Deviation 24.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 12. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).
Outcome measures
| Measure |
0.03 mg SM04690
n=103 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=102 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=101 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=101 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=105 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=105 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Pain in the Target Knee as Assesses by the Weekly Average of Daily Pain NRS
|
-2.75 score on a scale
Standard Deviation 2.22
|
-3.02 score on a scale
Standard Deviation 2.03
|
-2.21 score on a scale
Standard Deviation 2.23
|
-2.87 score on a scale
Standard Deviation 2.10
|
-2.15 score on a scale
Standard Deviation 2.39
|
-2.27 score on a scale
Standard Deviation 2.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Population: Data is reported as observed with no imputation. Discrepancy between the number of participants analyzed and the number of participants assigned to the arms is the result of missing data and/or subject withdrawal.
Change from baseline OA disease activity as assessed by PtGA at Week 12. The PtGA 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=100 Participants
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=93 Participants
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=94 Participants
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=101 Participants
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=99 Participants
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=104 Participants
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
|---|---|---|---|---|---|---|
|
Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment (PtGA)
|
-16.2 score on a scale
Standard Deviation 25.0
|
-20.0 score on a scale
Standard Deviation 28.0
|
-10.9 score on a scale
Standard Deviation 23.4
|
-18.4 score on a scale
Standard Deviation 24.9
|
-12.7 score on a scale
Standard Deviation 21.9
|
-12.7 score on a scale
Standard Deviation 22.9
|
Adverse Events
0.03 mg SM04690
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
0.07 mg SM04690
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
0.15 mg SM04690
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
0.23 mg SM04690
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Other
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.03 mg SM04690
n=106 participants at risk
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=104 participants at risk
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=106 participants at risk
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=106 participants at risk
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=114 participants at risk
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=120 participants at risk
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
Other
n=39 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
Coronary artery disease
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
Other adverse events
| Measure |
0.03 mg SM04690
n=106 participants at risk
Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle
|
0.07 mg SM04690
n=104 participants at risk
Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle
|
0.15 mg SM04690
n=106 participants at risk
Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle
|
0.23 mg SM04690
n=106 participants at risk
Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle
|
Placebo
n=114 participants at risk
Single intra-articular injection of 0 mg SM04690 in 2 mL vehicle
|
Sham
n=120 participants at risk
Single intra-articular injection of 0 mg SM04690 in 0 mL vehicle
|
Other
n=39 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.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
General disorders
Oedema peripheral
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Bronchitis
|
2.8%
3/106 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Sinusitis
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.8%
3/106 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
3.3%
4/120 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Skin infection
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
2/106 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
4.8%
5/104 • Number of events 5 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.8%
3/106 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
3.5%
4/114 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
3.3%
4/120 • Number of events 5 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
3.3%
4/120 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.9%
2/106 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
1.9%
2/104 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
3/114 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.83%
1/120 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.8%
3/106 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
6/106 • Number of events 6 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
6.7%
7/104 • Number of events 8 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
1.9%
2/106 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
8.5%
9/106 • Number of events 12 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
3/114 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
5.8%
7/120 • Number of events 7 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
7.7%
3/39 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.5%
3/120 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.8%
3/106 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
1.7%
2/120 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
3.3%
4/120 • Number of events 4 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
1.8%
2/114 • Number of events 2 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.83%
1/120 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Nervous system disorders
Headache
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.96%
1/104 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.8%
3/106 • Number of events 6 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Renal and urinary disorders
Haematuria
|
0.94%
1/106 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.8%
3/106 • Number of events 3 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.88%
1/114 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/39 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
|
Vascular disorders
Flushing
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/104 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/106 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/114 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
0.00%
0/120 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
2.6%
1/39 • Number of events 1 • Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that occur during the course of the study that are not present prior to Day 1 study medication injection, or, if present at the time of study medication injection, have worsened in severity during the course of the study. TEAEs were assessed at each study visit from the time of study medication injection on study visit Day 1 through Week 24 (End-of-Study)/Early Termination.
The Safety Analyses Set \[SAS\] includes all subjects who received a study injection, analyzed as treated. Discrepancy in subject counts between SAS and Full Analysis Set \[FAS\] is the result of subjects who received a treatment that is different from the planned treatment group as randomized. Subjects who received a study treatment not as prescribed in the pharmacy manual are summarized in the "Other" treatment group for safety analysis reporting.
|
Additional Information
Christopher Swearingen, PhD, VP of Biometrics
Biosplice Therapeutics, Inc.
Phone: 858.926.2952
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place