Trial Outcomes & Findings for APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA) (NCT NCT02138890)
NCT ID: NCT02138890
Last Updated: 2021-02-05
Results Overview
The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain).
COMPLETED
NA
46 participants
6 months
2021-02-05
Participant Flow
Multicenter study, with 4 centers in Belgium, Italy, Austria and Norway. The first subject was enrolled on 8 May 2014.
Participant milestones
| Measure |
APS Injection
Autologous Protein Solution
APS: Intra-articular Injection
|
Control
Saline: Intra-articular injection
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
15
|
|
Overall Study
COMPLETED
|
30
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
APS Injection
Autologous Protein Solution
APS: Intra-articular Injection
|
Control
Saline: Intra-articular injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA)
Baseline characteristics by cohort
| Measure |
APS Injection
n=31 Participants
Autologous Protein Solution (APS): Intra-articular Injection
|
Control
n=15 Participants
Saline: Intra-articular injection
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
n=5 Participants
|
54.1 years
n=7 Participants
|
55.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The safety/ITT population analysis population was utilized for this analysis.
The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain).
Outcome measures
| Measure |
APS Injection
n=31 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=15 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)
Day 1
|
11.5 scores on a scale
Standard Deviation 2.4
|
11.8 scores on a scale
Standard Deviation 1.9
|
|
Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)
Week 2
|
8.6 scores on a scale
Standard Deviation 4.0
|
8.7 scores on a scale
Standard Deviation 4.1
|
|
Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)
1 Months
|
7.0 scores on a scale
Standard Deviation 4.1
|
8.4 scores on a scale
Standard Deviation 3.4
|
|
Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)
3 Months
|
5.6 scores on a scale
Standard Deviation 3.9
|
5.7 scores on a scale
Standard Deviation 4.2
|
|
Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)
6 Months
|
5.0 scores on a scale
Standard Deviation 3.8
|
5.6 scores on a scale
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: This data describes mITT/PP analysis set
The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain).
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
Day 1
|
11.5 scores on a scale
Standard Deviation 2.4
|
11.8 scores on a scale
Standard Deviation 1.9
|
|
Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
Week 2
|
8.6 scores on a scale
Standard Deviation 4.0
|
8.7 scores on a scale
Standard Deviation 4.1
|
|
Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
1 Month
|
7.0 scores on a scale
Standard Deviation 4.1
|
8.4 scores on a scale
Standard Deviation 3.4
|
|
Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
3 Months
|
5.6 scores on a scale
Standard Deviation 3.9
|
5.7 scores on a scale
Standard Deviation 4.2
|
|
Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
6 Months
|
5.0 scores on a scale
Standard Deviation 3.8
|
5.6 scores on a scale
Standard Deviation 4.1
|
|
Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.
12 Months
|
4.3 scores on a scale
Standard Deviation 4.0
|
6.3 scores on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
5.5 scores on a scale
Standard Deviation 2.2
|
6.5 scores on a scale
Standard Deviation 1.8
|
|
Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
4.7 scores on a scale
Standard Deviation 2.6
|
5.3 scores on a scale
Standard Deviation 2.0
|
|
Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
4.0 scores on a scale
Standard Deviation 2.3
|
5.2 scores on a scale
Standard Deviation 2.1
|
|
Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
3.3 scores on a scale
Standard Deviation 2.0
|
3.9 scores on a scale
Standard Deviation 2.1
|
|
Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
3.1 scores on a scale
Standard Deviation 2.5
|
4.1 scores on a scale
Standard Deviation 2.3
|
|
Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
12 Months
|
2.6 scores on a scale
Standard Deviation 2.5
|
4.8 scores on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC Stiffness subscale consisted of two questions scored from 0 to 4. The Stiffness has a range of 0(no stiffness) to 8 (maximal stiffness)
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
4.8 scores on a scale
Standard Deviation 1.7
|
5.0 scores on a scale
Standard Deviation 1.2
|
|
Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
4.0 scores on a scale
Standard Deviation 2.0
|
3.6 scores on a scale
Standard Deviation 1.6
|
|
Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
3.3 scores on a scale
Standard Deviation 1.8
|
3.9 scores on a scale
Standard Deviation 1.3
|
|
Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
3.0 scores on a scale
Standard Deviation 1.6
|
3.4 scores on a scale
Standard Deviation 1.5
|
|
Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
2.7 scores on a scale
Standard Deviation 2.0
|
2.9 scores on a scale
Standard Deviation 1.6
|
|
Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
2.7 scores on a scale
Standard Deviation 1.7
|
3.0 scores on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC Physical Functioning subscale consisted of seventeen questions scored from 0 to 4. The Physical Functioning has a range of 0 (no functional limitation) to 68 (maximal functional limitation)
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
34.9 scores on a scale
Standard Deviation 12.4
|
38.1 scores on a scale
Standard Deviation 9.3
|
|
Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
30.2 scores on a scale
Standard Deviation 14.8
|
29.4 scores on a scale
Standard Deviation 15.1
|
|
Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
24.9 scores on a scale
Standard Deviation 14.7
|
28.9 scores on a scale
Standard Deviation 10.8
|
|
Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
21.5 scores on a scale
Standard Deviation 14.5
|
20.4 scores on a scale
Standard Deviation 13.4
|
|
Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
18.5 scores on a scale
Standard Deviation 13.0
|
18.0 scores on a scale
Standard Deviation 12.7
|
|
Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
15.6 scores on a scale
Standard Deviation 13.8
|
20.4 scores on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
58.2 scores on a scale
Standard Deviation 19.5
|
51.8 scores on a scale
Standard Deviation 16.3
|
|
Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
39.9 scores on a scale
Standard Deviation 13.1
|
37.9 scores on a scale
Standard Deviation 10.1
|
|
Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
51.1 scores on a scale
Standard Deviation 19.7
|
48.0 scores on a scale
Standard Deviation 16.6
|
|
Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
64.1 scores on a scale
Standard Deviation 20.7
|
64.7 scores on a scale
Standard Deviation 20.8
|
|
Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
66.6 scores on a scale
Standard Deviation 20.3
|
65.9 scores on a scale
Standard Deviation 19.2
|
|
Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
70.6 scores on a scale
Standard Deviation 21.5
|
61.1 scores on a scale
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
67.2 scores on a scale
Standard Deviation 20.3
|
63.3 scores on a scale
Standard Deviation 15.1
|
|
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
47.8 scores on a scale
Standard Deviation 19.3
|
46.4 scores on a scale
Standard Deviation 12.1
|
|
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
2 Weeks
|
55.4 scores on a scale
Standard Deviation 22.0
|
54.9 scores on a scale
Standard Deviation 17.1
|
|
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
64.2 scores on a scale
Standard Deviation 20.4
|
56.1 scores on a scale
Standard Deviation 15.3
|
|
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
65.3 scores on a scale
Standard Deviation 17.4
|
62.5 scores on a scale
Standard Deviation 14.6
|
|
Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
68.4 scores on a scale
Standard Deviation 21.4
|
58.2 scores on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
48.6 scores on a scale
Standard Deviation 18.3
|
44.0 scores on a scale
Standard Deviation 13.7
|
|
Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
55.5 scores on a scale
Standard Deviation 21.8
|
56.8 scores on a scale
Standard Deviation 22.2
|
|
Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
63.4 scores on a scale
Standard Deviation 21.6
|
57.5 scores on a scale
Standard Deviation 15.9
|
|
Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
68.3 scores on a scale
Standard Deviation 21.3
|
70.0 scores on a scale
Standard Deviation 19.8
|
|
Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
72.8 scores on a scale
Standard Deviation 19.1
|
73.5 scores on a scale
Standard Deviation 18.7
|
|
Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
77.0 scores on a scale
Standard Deviation 20.3
|
70.0 scores on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
23.1 scores on a scale
Standard Deviation 25
|
14.3 scores on a scale
Standard Deviation 9.4
|
|
Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
29.0 scores on a scale
Standard Deviation 22.4
|
23.2 scores on a scale
Standard Deviation 15.3
|
|
Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
30.7 scores on a scale
Standard Deviation 27.6
|
26.6 scores on a scale
Standard Deviation 18.8
|
|
Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
37.7 scores on a scale
Standard Deviation 27.1
|
40.2 scores on a scale
Standard Deviation 25.1
|
|
Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
39.1 scores on a scale
Standard Deviation 25.3
|
42.1 scores on a scale
Standard Deviation 23.7
|
|
Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
47.1 scores on a scale
Standard Deviation 29.5
|
37.1 scores on a scale
Standard Deviation 27.9
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Day 1
|
26.5 score on a scale
Standard Deviation 13.8
|
22.3 score on a scale
Standard Deviation 8.7
|
|
Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Week 2
|
29.0 score on a scale
Standard Deviation 22.4
|
23.2 score on a scale
Standard Deviation 15.3
|
|
Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
1 Month
|
30.7 score on a scale
Standard Deviation 27.6
|
26.8 score on a scale
Standard Deviation 18.8
|
|
Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
3 Months
|
37.7 score on a scale
Standard Deviation 27.1
|
40.2 score on a scale
Standard Deviation 25.1
|
|
Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
6 Months
|
39.1 score on a scale
Standard Deviation 25.3
|
42.1 score on a scale
Standard Deviation 23.7
|
|
Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months
Month 12
|
51.3 score on a scale
Standard Deviation 25.3
|
38.4 score on a scale
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Eight subscales of the Short Form-36 questionnaire are used to derive Physical Component and Mental Component measures
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
35.8 score on a scale
Standard Deviation 10.0
|
33.9 score on a scale
Standard Deviation 9.4
|
|
Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months
6 Months
|
43.3 score on a scale
Standard Deviation 9.2
|
42.0 score on a scale
Standard Deviation 9.6
|
|
Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
43.5 score on a scale
Standard Deviation 10.2
|
42.2 score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
51.5 scores on a scale
Standard Deviation 8.5
|
50.8 scores on a scale
Standard Deviation 8.9
|
|
Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
54.1 scores on a scale
Standard Deviation 7.7
|
53.8 scores on a scale
Standard Deviation 6.0
|
|
Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
55.2 scores on a scale
Standard Deviation 7.4
|
53.0 scores on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
44.1 scores on a scale
Standard Deviation 12.4
|
45.7 scores on a scale
Standard Deviation 11.1
|
|
Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
46.0 scores on a scale
Standard Deviation 10.9
|
42.4 scores on a scale
Standard Deviation 9.3
|
|
Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
38.5 scores on a scale
Standard Deviation 12.0
|
38.8 scores on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
36.7 scores on a scale
Standard Deviation 7.6
|
35.0 scores on a scale
Standard Deviation 7.9
|
|
Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
44.0 scores on a scale
Standard Deviation 10.9
|
43.7 scores on a scale
Standard Deviation 7.2
|
|
Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
47.0 scores on a scale
Standard Deviation 9.3
|
39.2 scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
36.7 scores on a scale
Standard Deviation 7.6
|
35.0 scores on a scale
Standard Deviation 7.9
|
|
General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
44.0 scores on a scale
Standard Deviation 10.9
|
43.7 scores on a scale
Standard Deviation 7.2
|
|
General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
47.0 scores on a scale
Standard Deviation 9.3
|
39.2 scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
54.6 scores on a scale
Standard Deviation 9.9
|
53.1 scores on a scale
Standard Deviation 6.2
|
|
Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
51.7 scores on a scale
Standard Deviation 9.9
|
50.6 scores on a scale
Standard Deviation 7.6
|
|
Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
54.0 scores on a scale
Standard Deviation 8.8
|
52.4 scores on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
43.7 scores on a scale
Standard Deviation 10.9
|
44.5 scores on a scale
Standard Deviation 10.8
|
|
Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
49.6 scores on a scale
Standard Deviation 9.7
|
51.4 scores on a scale
Standard Deviation 7.4
|
|
Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
51.5 scores on a scale
Standard Deviation 8.3
|
47.6 scores on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
APS Injection
n=29 Participants
Autologous Protein Solution: Intra-articular Injection
|
Control
n=14 Participants
Saline: Intra-articular injection
|
|---|---|---|
|
Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months
Day 1
|
44.0 scores on a scale
Standard Deviation 13.7
|
39.5 scores on a scale
Standard Deviation 13.5
|
|
Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months
Month 6
|
48.1 scores on a scale
Standard Deviation 10.7
|
47.5 scores on a scale
Standard Deviation 10.4
|
|
Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months
Month 12
|
49.6 scores on a scale
Standard Deviation 10.5
|
42.5 scores on a scale
Standard Deviation 9.8
|
Adverse Events
APS Injection
Control
Serious adverse events
| Measure |
APS Injection
n=31 participants at risk
Autologous Protein Solution: Intra-articular Injection
|
Control
n=15 participants at risk
Saline: Intra-articular injection
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
Other adverse events
| Measure |
APS Injection
n=31 participants at risk
Autologous Protein Solution: Intra-articular Injection
|
Control
n=15 participants at risk
Saline: Intra-articular injection
|
|---|---|---|
|
Gastrointestinal disorders
Toothache
|
6.5%
2/31 • Number of events 4 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 2 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Hepatobiliary disorders
cholelithiasis
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Immune system disorders
hypersensitivity
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Influenza
|
6.5%
2/31 • Number of events 2 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Metabolism and nutrition disorders
Vitamine D Deficiency
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
5/31 • Number of events 6 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
20.0%
3/15 • Number of events 7 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Number of events 4 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Psychiatric disorders
Alcoholic hangover
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Number of events 2 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
General disorders
pyrexia
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
General disorders
influenza like ilness
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Gastrointestinal infection
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.1%
5/31 • Number of events 8 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal Pain
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.5%
2/31 • Number of events 2 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.5%
2/31 • Number of events 2 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/31 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
6.7%
1/15 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
3.2%
1/31 • Number of events 1 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
0.00%
0/15 • Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60