Trial Outcomes & Findings for A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s) (NCT NCT01586338)
NCT ID: NCT01586338
Last Updated: 2016-02-24
Results Overview
WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
237 participants
Primary outcome timeframe
Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])
Results posted on
2016-02-24
Participant Flow
The study was conducted at 10 centers in China. A total of 237 participants were enrolled between March 09, 2012 and February 28, 2013.
Of 237 enrolled participants 232 participants were treated. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).
Participant milestones
| Measure |
Synvisc
Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
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|---|---|
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Overall Study
STARTED
|
237
|
|
Overall Study
COMPLETED
|
229
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Synvisc
Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Withdrawal by participant
|
3
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Baseline characteristics by cohort
| Measure |
Synvisc
n=237 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
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|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])Population: Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).
WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Outcome measures
| Measure |
Synvisc
n=232 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
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|---|---|
|
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
|
-33.0 mm
Standard Deviation 17.71
|
PRIMARY outcome
Timeframe: Up to Week 26Population: Safety Set included all participants who received at least one injection of Synvisc.
An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study drug until the end of study period). Category "AE" included participant with both serious and non-serious AE.
Outcome measures
| Measure |
Synvisc
n=237 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
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|---|---|
|
Overview of Adverse Events (AE)
AEs
|
27.8 percentage of participants
|
|
Overview of Adverse Events (AE)
Treatment-emergent AEs
|
27.8 percentage of participants
|
|
Overview of Adverse Events (AE)
Treatment-emergent SAEs
|
1.7 percentage of participants
|
|
Overview of Adverse Events (AE)
Treatment-emergent AEs Lead to Discontinuation
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8 and Week 12 (missing data imputed by LOCF)Population: FAS population.
WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Outcome measures
| Measure |
Synvisc
n=232 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
Change form baseline at Week 8
|
-26.0 mm
Standard Deviation 17.68
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|
Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
Change form baseline at Week 12
|
-30.0 mm
Standard Deviation 17.43
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)Population: FAS population.
WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.
Outcome measures
| Measure |
Synvisc
n=232 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC A: Change from baseline at Week 8
|
-92.7 mm
Standard Deviation 71.77
|
|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC A: Change from baseline at Week 12
|
-109.8 mm
Standard Deviation 73.68
|
|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC A: Change from baseline at Week 26
|
-121.5 mm
Standard Deviation 77.18
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|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC B: Change from baseline at Week 8
|
-28.9 mm
Standard Deviation 37.53
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|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC B: Change from baseline at Week 12
|
-34.6 mm
Standard Deviation 38.44
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|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC B: Change from baseline at Week 26
|
-36.6 mm
Standard Deviation 39.75
|
|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC C: Change from baseline at Week 8
|
-270.0 mm
Standard Deviation 252.86
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|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC C: Change from baseline at Week 12
|
-325.9 mm
Standard Deviation 258.57
|
|
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
WOMAC C: Change from baseline at Week 26
|
-358.4 mm
Standard Deviation 270.48
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)Population: FAS population.
PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.
Outcome measures
| Measure |
Synvisc
n=232 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Patient Global Assessment (PTGA) Score
Baseline: Very Well
|
0.0 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Baseline: Well
|
1.3 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Baseline: Fair
|
29.3 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Baseline: Poor
|
60.3 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Baseline: Very Poor
|
9.1 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 8: Very Well
|
4.3 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 8: Well
|
41.8 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 8: Fair
|
46.1 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 8 : Poor
|
6.9 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 8: Very Poor
|
0.9 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 12: Very Well
|
5.2 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 12: Well
|
44.4 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 12: Fair
|
44.0 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 12: Poor
|
6.0 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 12: Very Poor
|
0.4 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 26: Very Well
|
8.2 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 26: Well
|
46.6 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 26: Fair
|
37.1 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 26: Poor
|
7.8 percentage of participants
|
|
Patient Global Assessment (PTGA) Score
Week 26: Very Poor
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)Population: FAS population.
COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant's osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.
Outcome measures
| Measure |
Synvisc
n=232 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Clinical Observer Global Assessment (COGA) Score
Baseline: Very Well
|
0.0 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Baseline: Well
|
1.7 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Baseline: Fair
|
35.3 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Baseline: Poor
|
57.3 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Baseline: Very Poor
|
5.6 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 8: Very Well
|
5.2 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 8: Well
|
42.7 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 8: Fair
|
41.8 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 8: Poor
|
9.9 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 8: Very Poor
|
0.4 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 12: Very Well
|
7.3 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 12: Well
|
44.4 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 12: Fair
|
41.8 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 12: Poor
|
6.0 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 12: Very Poor
|
0.4 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 26: Very Well
|
9.5 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 26: Well
|
47.4 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 26: Fair
|
35.3 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 26: Poor
|
7.8 percentage of participants
|
|
Clinical Observer Global Assessment (COGA) Score
Week 26: Very Poor
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: FAS population.
Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.
Outcome measures
| Measure |
Synvisc
n=232 Participants
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Required Less Use of Other Therapies
|
2.2 percentage participants
|
|
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Required More Use of Other Therapies
|
3.0 percentage participants
|
|
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Required No Change in Use of Other Therapies
|
93.1 percentage participants
|
|
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Missing
|
1.7 percentage participants
|
Adverse Events
Synvisc
Serious events: 4 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synvisc
n=237 participants at risk
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Injury, poisoning and procedural complications
Meniscal Injury
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
Other adverse events
| Measure |
Synvisc
n=237 participants at risk
Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
|
|---|---|
|
Gastrointestinal disorders
Toothache
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
22/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.84%
2/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.84%
2/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Amyasthenia
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Extremitiess Pain
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Musculoskeletal and connective tissue disorders
Vertebral Disc Prolapsed
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.2%
17/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Infections and infestations
Urinary Tract Infection
|
1.3%
3/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Infections and infestations
Herpes Zoster
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Infections and infestations
Hand Infection
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Infections and infestations
Infectious Pneumonia
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
General disorders
Pain in the Area of Injection Site
|
2.1%
5/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
General disorders
Weakness
|
0.84%
2/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
General disorders
Swelling in the Area of Injection Site
|
0.84%
2/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
General disorders
Warmth
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
General disorders
Joint Effusion in the Area of Injection Site
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Astriction
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Gingivitis
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Diarrhea
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Atrophic Gastritis
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Injury, poisoning and procedural complications
Ligament Spain
|
1.7%
4/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Injury, poisoning and procedural complications
Meniscal Injury
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Injury, poisoning and procedural complications
Extremities Injury
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Injury, poisoning and procedural complications
Humeral Fracture
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Skin and subcutaneous tissue disorders
Night Sweat
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Psychiatric disorders
Migraine
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Psychiatric disorders
Dizziness
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Psychiatric disorders
Cramp
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Ear and labyrinth disorders
Vertigo
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Reproductive system and breast disorders
Colporrhagia
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Eye disorders
Retinal Hemorrhage
|
0.42%
1/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
3/237 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the time of signing the informed consent until completion of the study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER