Trial Outcomes & Findings for Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment (NCT NCT03330288)
NCT ID: NCT03330288
Last Updated: 2021-10-14
Results Overview
KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method.
COMPLETED
1102 participants
From enrollment up to 64 weeks
2021-10-14
Participant Flow
Study was conducted at 51 centers in Russian Federation, between 20-Nov-2017 (first participant first visit) and 13-Jul-2020 (Database clean). The Primary Completion date is 18-Mar-2020 (last participant last visit)
A total of 1111 participants were screened over the course of the study, of which 1102 participants were enrolled in the study. Among them, 824 participants were diagnosed with knee osteoarthritis (KOA), while 278 participants were diagnosed with hip osteoarthritis (HOA).
Participant milestones
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Overall Study
STARTED
|
824
|
278
|
|
Overall Study
COMPLETED
|
794
|
270
|
|
Overall Study
NOT COMPLETED
|
30
|
8
|
Reasons for withdrawal
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Overall Study
Other reason
|
1
|
1
|
|
Overall Study
Switching to a different disease-modifying delayed-release drug SYSADOA
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
26
|
7
|
Baseline Characteristics
KOA patients and HOA patients are reported separately for each Arm of the study
Baseline characteristics by cohort
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Total
n=1102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
60.3 Years
STANDARD_DEVIATION 7.21 • n=7 Participants
|
60.4 Years
STANDARD_DEVIATION 6.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
728 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
968 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
820 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
1098 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Pain intensity subscale
|
61.48 Scores on a scale
STANDARD_DEVIATION 16.434 • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
60.97 Scores on a scale
STANDARD_DEVIATION 17.321 • n=7 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
NA Scores on a scale
STANDARD_DEVIATION NA • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
|
Other symptom subscale
|
62.25 Scores on a scale
STANDARD_DEVIATION 18.034 • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
61.17 Scores on a scale
STANDARD_DEVIATION 17.691 • n=7 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
NA Scores on a scale
STANDARD_DEVIATION NA • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
|
Functional activity of the joint subscale
|
61.46 Scores on a scale
STANDARD_DEVIATION 10.599 • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
65.57 Scores on a scale
STANDARD_DEVIATION 16.515 • n=7 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
NA Scores on a scale
STANDARD_DEVIATION NA • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
|
Life quality subscale
|
44.99 Scores on a scale
STANDARD_DEVIATION 17.009 • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
46.79 Scores on a scale
STANDARD_DEVIATION 17.507 • n=7 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
NA Scores on a scale
STANDARD_DEVIATION NA • n=5 Participants • KOA patients and HOA patients are reported separately for each Arm of the study
|
|
Patient satisfaction assessment
|
3.2 Scores on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.1 Scores on a scale
STANDARD_DEVIATION 0.42 • n=7 Participants
|
3.1 Scores on a scale
STANDARD_DEVIATION 0.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to 64 weeksPopulation: The outcome measure was analyzed based on participants who has KOOS/HOOS assessment.
KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Changes in the Pain Intensity Subscale
From Visit 1(enrollment) to Visit 2 (Week 16-24)
|
18.07 Scores on a scale
Standard Deviation 16.900
|
15.59 Scores on a scale
Standard Deviation 16.686
|
|
Changes in the Pain Intensity Subscale
From Visit 1(enrollment) toVisit 3 (Week 36-44)
|
20.92 Scores on a scale
Standard Deviation 17.946
|
20.06 Scores on a scale
Standard Deviation 17.686
|
|
Changes in the Pain Intensity Subscale
From Visit 1(enrollment) toVisit 4 (Week 56-64)
|
22.87 Scores on a scale
Standard Deviation 18.815
|
22.81 Scores on a scale
Standard Deviation 19.550
|
PRIMARY outcome
Timeframe: From enrollment up to 64 weeksPopulation: The outcome measure was analyzed based on participants who has KOOS/HOOS assessment.
KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Other symptoms is one subscale of KOOS and HOOS questionnaire, each other symptoms question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS other symptoms subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS other symptoms subscale results calculation used a similar method.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Changes in Other Symptoms Subscale
From Visit 1(enrollment) to Visit 2 (Week 16-24)
|
15.48 Scores on a scale
Standard Deviation 17.465
|
12.65 Scores on a scale
Standard Deviation 16.937
|
|
Changes in Other Symptoms Subscale
From Visit 1(enrollment) toVisit 3 (Week 36-44)
|
18.87 Scores on a scale
Standard Deviation 18.685
|
17.10 Scores on a scale
Standard Deviation 17.811
|
|
Changes in Other Symptoms Subscale
From Visit 1(enrollment) toVisit 4 (Week 56-64)
|
20.78 Scores on a scale
Standard Deviation 19.330
|
19.93 Scores on a scale
Standard Deviation 20.318
|
PRIMARY outcome
Timeframe: From enrollment up to 64 weeksPopulation: The outcome measure was analyzed based on participants who has KOOS/HOOS assessment.
KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Functional activity is one subscale of KOOS and HOOS questionnaire, each functional activity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS functional activity subscale were calculated by converting value of all subscale questions to KOOS-Physical Short form score. Results score is from 0 to 100, 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS functional activity subscale results used a similar method with HOOS-Physical Short form.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Change in Functional Activity of the Joint Subscale
From Visit 1(enrollment) to Visit 2 (Week 16-24)
|
10.98 Scores on a scale
Standard Deviation 11.831
|
13.26 Scores on a scale
Standard Deviation 15.729
|
|
Change in Functional Activity of the Joint Subscale
From Visit 1(enrollment) to Visit 3 (Week 36-44)
|
14.26 Scores on a scale
Standard Deviation 13.708
|
16.41 Scores on a scale
Standard Deviation 16.584
|
|
Change in Functional Activity of the Joint Subscale
From Visit 1(enrollment) to Visit 4 (Week 56-64)
|
16.60 Scores on a scale
Standard Deviation 14.503
|
18.77 Scores on a scale
Standard Deviation 18.041
|
PRIMARY outcome
Timeframe: From enrollment up to 64 weeksPopulation: The outcome measure was analyzed based on participants who has KOOS/HOOS assessment.
KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Life quality is one subscale of KOOS and HOOS questionnaire, each life quality question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS life quality subscale were calculated as \[100 - (mean value of all subscale questions \* 100) / 4\]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS life quality subscale results calculation used a similar method.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Change in Life Quality Subscale
From Visit 1(enrollment) to Visit 2 (Week 16-24)
|
16.29 Scores on a scale
Standard Deviation 17.888
|
14.25 Scores on a scale
Standard Deviation 18.068
|
|
Change in Life Quality Subscale
From Visit 1(enrollment) to Visit 3 (Week 36-44)
|
20.79 Scores on a scale
Standard Deviation 19.625
|
18.82 Scores on a scale
Standard Deviation 18.915
|
|
Change in Life Quality Subscale
From Visit 1(enrollment) to Visit 4 (Week 56-64)
|
24.87 Scores on a scale
Standard Deviation 21.055
|
22.71 Scores on a scale
Standard Deviation 21.444
|
SECONDARY outcome
Timeframe: From enrollment up to 64 weeksDrug utilization of Theraflex as reported by the patient to their physician. Administration duration categories are: 1.patients receiving Theraflex up to 1 month inclusive; 2.patients taking Theraflex during 1 to 3 months; 3.patients taking Theraflex during 3 to 6 months; 4. patients taking Theraflex during more than 6 months. Investigators assessed compliance with the recommendations for the duration of Theraflex.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Number of Participant Compliance With Drug Utilization of Theraflex
Participant followed the recommendations
|
753 Participant
|
253 Participant
|
|
Number of Participant Compliance With Drug Utilization of Theraflex
Participant not followed the recommendations
|
59 Participant
|
21 Participant
|
|
Number of Participant Compliance With Drug Utilization of Theraflex
No data available
|
12 Participant
|
4 Participant
|
SECONDARY outcome
Timeframe: From enrollment up to 64 weeksPopulation: The outcome measure was analyzed based on participants who has KOOS/HOOS assessment.
Patient satisfaction questionnaire was filled out during the visit to a doctor. A patient assessed treatment satisfaction against the Likert response scale : 5-very satisfied, 4-Satisfied, 3- No answer, 2-Dissatisfied, 1-very dissatisfied
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Change in Patient Satisfaction Assessment
From Visit 1(enrollment) to Visit 2 (Week 16-24)
|
0.8 Scores on a scale
Standard Deviation 0.84
|
0.8 Scores on a scale
Standard Deviation 0.87
|
|
Change in Patient Satisfaction Assessment
From Visit 1(enrollment) to Visit 3 (Week 36-44)
|
0.8 Scores on a scale
Standard Deviation 0.89
|
0.9 Scores on a scale
Standard Deviation 0.81
|
|
Change in Patient Satisfaction Assessment
From Visit 1(enrollment) to Visit 4 (Week 56-64)
|
0.9 Scores on a scale
Standard Deviation 0.94
|
0.9 Scores on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: From enrollment up to 64 weeksConcomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)
Other therapy for the target joint OA
|
36 Participant
|
4 Participant
|
|
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)
Symptomatic therapy with analgesics for the target joint OA
|
274 Participant
|
103 Participant
|
|
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)
Other drug treatment for pain syndrome of the target joint OA
|
84 Participant
|
25 Participant
|
SECONDARY outcome
Timeframe: From enrollment up to 64 weeksConcomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'.
Outcome measures
| Measure |
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 Participants
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex
Symptomatic therapy with analgesics for the target joint OA
|
20 Participant
|
5 Participant
|
|
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex
Other drug treatment for pain syndrome of the target joint OA
|
11 Participant
|
6 Participant
|
|
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex
Other therapy for the target joint OA
|
9 Participant
|
0 Participant
|
Adverse Events
Participants With Stage I-III Hip Osteoarthritis (HOA)
Participants With Stage I-III Knee Osteoarthritis (KOA)
Serious adverse events
| Measure |
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 participants at risk
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 participants at risk
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.24%
2/824 • Number of events 2 • After initial administration of Theraflex up to 64 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Nervous system disorders
Radicular pain
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.36%
1/278 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
0.00%
0/824 • After initial administration of Theraflex up to 64 weeks.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/278 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
Other adverse events
| Measure |
Participants With Stage I-III Hip Osteoarthritis (HOA)
n=278 participants at risk
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
Participants With Stage I-III Knee Osteoarthritis (KOA)
n=824 participants at risk
Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
4/278 • Number of events 4 • After initial administration of Theraflex up to 64 weeks.
|
0.12%
1/824 • Number of events 1 • After initial administration of Theraflex up to 64 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.72%
2/278 • Number of events 2 • After initial administration of Theraflex up to 64 weeks.
|
1.5%
12/824 • Number of events 12 • After initial administration of Theraflex up to 64 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
7/278 • Number of events 7 • After initial administration of Theraflex up to 64 weeks.
|
2.2%
18/824 • Number of events 18 • After initial administration of Theraflex up to 64 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
3/278 • Number of events 3 • After initial administration of Theraflex up to 64 weeks.
|
0.61%
5/824 • Number of events 6 • After initial administration of Theraflex up to 64 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
4/278 • Number of events 4 • After initial administration of Theraflex up to 64 weeks.
|
0.24%
2/824 • Number of events 2 • After initial administration of Theraflex up to 64 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
4/278 • Number of events 4 • After initial administration of Theraflex up to 64 weeks.
|
1.1%
9/824 • Number of events 10 • After initial administration of Theraflex up to 64 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
1.1%
3/278 • Number of events 3 • After initial administration of Theraflex up to 64 weeks.
|
0.49%
4/824 • Number of events 5 • After initial administration of Theraflex up to 64 weeks.
|
|
Nervous system disorders
Headache
|
1.1%
3/278 • Number of events 5 • After initial administration of Theraflex up to 64 weeks.
|
1.3%
11/824 • Number of events 11 • After initial administration of Theraflex up to 64 weeks.
|
|
Vascular disorders
Hypertension
|
1.4%
4/278 • Number of events 4 • After initial administration of Theraflex up to 64 weeks.
|
0.24%
2/824 • Number of events 2 • After initial administration of Theraflex up to 64 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60