Trial Outcomes & Findings for A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis (NCT NCT02034409)
NCT ID: NCT02034409
Last Updated: 2021-10-18
Results Overview
Outcome Measures in Rheumatology Clinical Trials- Osteoarthritis Research Society International (OMERACT-OARSI) Response incorporates changes in pain and global assessment to define response in OA clinical trials. A response is classified as: 1) An improvement in either pain or function of at least 50 percent accompanied by an absolute decrease of at least 20 mm on the visual-analogue scale for pain or function, OR 2) The occurrence of at least two of the following: a) a decrease in pain of at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale; b) an improvement in function of at least 20 percent and a decrease of at least 10 mm on the visual-analogue scale; c) an increase in the patient's global assessment score by at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale
COMPLETED
PHASE1/PHASE2
140 participants
48 weeks
2021-10-18
Participant Flow
Participants were recruited at 2 medical centers between May 2015 and January 2019. The first participant was enrolled May 2017 and the last participant was enrolled in January 2019.
140 participants began, and 136 completed, the 4-Week Sham Run-in Period. 4 of the 140 Sham Run-in participants were withdrawn due to being less than 80% treatment compliance.
Participant milestones
| Measure |
Sham
Treatment to index knee with sham device for 48 weeks
ShamComparator: 20 minutes daily for 48 weeks
|
PLIUS (Pulsed Low Intensity UltraSound)
Treatment to index knee with PLIUS device for 48 weeks
PLIUS device: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Sham Run-in Period
STARTED
|
140
|
0
|
|
Sham Run-in Period
COMPLETED
|
136
|
0
|
|
Sham Run-in Period
NOT COMPLETED
|
4
|
0
|
|
Sham-Controlled Treatment Period
STARTED
|
67
|
69
|
|
Sham-Controlled Treatment Period
COMPLETED
|
55
|
54
|
|
Sham-Controlled Treatment Period
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Sham
Treatment to index knee with sham device for 48 weeks
ShamComparator: 20 minutes daily for 48 weeks
|
PLIUS (Pulsed Low Intensity UltraSound)
Treatment to index knee with PLIUS device for 48 weeks
PLIUS device: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Sham Run-in Period
Participants withdrawn per protocol because less than 80% treatment compliance
|
4
|
0
|
|
Sham-Controlled Treatment Period
Adverse Event
|
1
|
1
|
|
Sham-Controlled Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Sham-Controlled Treatment Period
Withdrawal by Subject
|
8
|
8
|
|
Sham-Controlled Treatment Period
Physician Decision
|
1
|
3
|
|
Sham-Controlled Treatment Period
misrandomized
|
2
|
2
|
Baseline Characteristics
Needed data for baseline measure only available for 130 participants
Baseline characteristics by cohort
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.9 • n=65 Participants
|
62.9 years
STANDARD_DEVIATION 10.5 • n=67 Participants
|
63.6 years
STANDARD_DEVIATION 10.7 • n=132 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=65 Participants
|
6 Participants
n=67 Participants
|
13 Participants
n=132 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=65 Participants
|
61 Participants
n=67 Participants
|
119 Participants
n=132 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=65 Participants
|
13 Participants
n=67 Participants
|
23 Participants
n=132 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=65 Participants
|
54 Participants
n=67 Participants
|
109 Participants
n=132 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=65 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=132 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=65 Participants
|
0 Participants
n=67 Participants
|
1 Participants
n=132 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=65 Participants
|
3 Participants
n=67 Participants
|
6 Participants
n=132 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=65 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=132 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=65 Participants
|
5 Participants
n=67 Participants
|
10 Participants
n=132 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=65 Participants
|
48 Participants
n=67 Participants
|
100 Participants
n=132 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=65 Participants
|
9 Participants
n=67 Participants
|
12 Participants
n=132 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=65 Participants
|
2 Participants
n=67 Participants
|
3 Participants
n=132 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=65 Participants
|
67 Participants
n=67 Participants
|
132 Participants
n=132 Participants
|
|
BMI
|
31.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=64 Participants • Needed data for baseline measure only available for 130 participants
|
31.8 kg/m^2
STANDARD_DEVIATION 5.4 • n=66 Participants • Needed data for baseline measure only available for 130 participants
|
31.7 kg/m^2
STANDARD_DEVIATION 5.5 • n=130 Participants • Needed data for baseline measure only available for 130 participants
|
|
Years with Osteoarthritis
|
11.7 years
STANDARD_DEVIATION 11.2 • n=65 Participants
|
15.0 years
STANDARD_DEVIATION 13.2 • n=67 Participants
|
13.4 years
STANDARD_DEVIATION 12.3 • n=132 Participants
|
|
ARA Functional Class
Class I
|
0 Participants
n=65 Participants
|
2 Participants
n=67 Participants
|
2 Participants
n=132 Participants
|
|
ARA Functional Class
Class II
|
48 Participants
n=65 Participants
|
52 Participants
n=67 Participants
|
100 Participants
n=132 Participants
|
|
ARA Functional Class
Class III
|
17 Participants
n=65 Participants
|
13 Participants
n=67 Participants
|
30 Participants
n=132 Participants
|
|
ARA Functional Class
Class IV
|
0 Participants
n=65 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=132 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Participants with baseline and 48 week values.
Outcome Measures in Rheumatology Clinical Trials- Osteoarthritis Research Society International (OMERACT-OARSI) Response incorporates changes in pain and global assessment to define response in OA clinical trials. A response is classified as: 1) An improvement in either pain or function of at least 50 percent accompanied by an absolute decrease of at least 20 mm on the visual-analogue scale for pain or function, OR 2) The occurrence of at least two of the following: a) a decrease in pain of at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale; b) an improvement in function of at least 20 percent and a decrease of at least 10 mm on the visual-analogue scale; c) an increase in the patient's global assessment score by at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale
Outcome measures
| Measure |
Sham
n=55 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=54 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness
OMERACT-OARSI responders
|
37 Participants
|
38 Participants
|
|
Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness
OMERACT-OARSI non-responders
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Baseline, 48 weeksPopulation: Participants with baseline and 48 week value
The study has been designed to determine if PLIUS potentially diminishes articular cartilage thinning by measuring cartilage thickness in the tibial femoral joint. The measure selected to best evaluate this is cartilage thickness of the central medial femoral condyle because studies of the OAI (Osteoarthritis Initiative) data have shown this region to be among those most sensitive to change and, due to the anatomical positioning of the device, the most likely to be affected by treatment.
Outcome measures
| Measure |
Sham
n=50 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=48 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Co-Primary Measure: b) Disease Modification as Measured by Change From Baseline in Cartilage Thickness of the Central Medial Femoral Condyle Disease
|
-42.2 μm
Standard Deviation 297.0
|
-73.8 μm
Standard Deviation 168.1
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
The WOMAC® Index questionnaire is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 200. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in WOMAC Stiffness Subscale Score
Change from Baseline to week 24
|
-33.6 Visual Analog Scale (mm)
Interval -47.6 to -19.7
|
-27.7 Visual Analog Scale (mm)
Interval -40.2 to -15.1
|
|
Change From Baseline in WOMAC Stiffness Subscale Score
Change from Baseline to week 48
|
-49.8 Visual Analog Scale (mm)
Interval -64.6 to -35.1
|
-37.1 Visual Analog Scale (mm)
Interval -51.6 to -22.6
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
The WOMAC® Index questionnaire \[33\] is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. WOMAC pain scores from 0-500 mm. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in WOMAC Pain Subscale Score
Change from Baseline to week 24
|
-84.2 Visual Analog Scale mm
Interval -109.4 to -58.9
|
-91.4 Visual Analog Scale mm
Interval -111.1 to -71.7
|
|
Change From Baseline in WOMAC Pain Subscale Score
Change from Baseline to week 48
|
-117.1 Visual Analog Scale mm
Interval -146.2 to -87.9
|
-93.4 Visual Analog Scale mm
Interval -124.4 to -62.3
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
The WOMAC® Index questionnaire \[33\] is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 1700. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in WOMAC Functional Limits Subscale Score
Change from Baseline to week 24
|
-285.2 Visual Analog Scale (mm)
Interval -377.1 to -193.2
|
-241.1 Visual Analog Scale (mm)
Interval -316.9 to -165.4
|
|
Change From Baseline in WOMAC Functional Limits Subscale Score
Change from Baseline to week 48
|
-407.3 Visual Analog Scale (mm)
Interval -510.8 to -303.7
|
-283.1 Visual Analog Scale (mm)
Interval -399.7 to -166.5
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
The WOMAC® Index questionnaire is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 2400. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in Total WOMAC Score
Change from Baseline to week 24
|
-403.0 Visual Analog Scale (mm)
Interval -527.3 to -278.6
|
-360.2 Visual Analog Scale (mm)
Interval -460.8 to -259.5
|
|
Change From Baseline in Total WOMAC Score
Change from Baseline to week 48
|
-574.1 Visual Analog Scale (mm)
Interval -713.8 to -434.4
|
-413.6 Visual Analog Scale (mm)
Interval -571.4 to -255.7
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
A patient global assessment of disease status on a Visual Analog Scale (VAS) will be measured at each clinic visit. Patients will be asked to quantify their disease status on a 100 mm VAS as follows: "Considering all the ways your arthritis of the knee affects you, mark 'X' on the scale for how well you are doing." The scale shows the left hand marker "Very Well", and the right hand marker "Very Poor." Range 0 to 100 mm. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in Patient Global Assessment of Disease Status
Change from Baseline to Week 24
|
-16.6 Visual Analog Scale (mm)
Interval -23.3 to -9.9
|
-15.0 Visual Analog Scale (mm)
Interval -21.4 to -8.7
|
|
Change From Baseline in Patient Global Assessment of Disease Status
Change from Baseline to Week 48
|
-23.7 Visual Analog Scale (mm)
Interval -30.8 to -16.5
|
-17.6 Visual Analog Scale (mm)
Interval -26.3 to -9.0
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
An investigator global assessment of disease status on a 100 mm VAS was measured at each clinic visit as follows: "Make a global assessment of the patient's disease status, with regard to the index knee, by marking an 'X' on the scale below.", with left hand marker "Very Well" and right hand marker "Very Poor." Range 0 to 100 mm. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in Investigator Global Assessment of Disease Status
Change from Baseline to Week 24
|
-18.4 Visual Analog Scale (mm)
Interval -25.0 to -11.9
|
-15.8 Visual Analog Scale (mm)
Interval -22.5 to -9.0
|
|
Change From Baseline in Investigator Global Assessment of Disease Status
Change from Baseline to Week 48
|
-28.6 Visual Analog Scale (mm)
Interval -36.6 to -20.6
|
-18.9 Visual Analog Scale (mm)
Interval -27.9 to -9.9
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent To Treat
This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered. Study participants are asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants responded to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale
Change from Baseline to Week 24
|
-14.6 Visual Analog Scale (mm)
Interval -20.1 to 9.1
|
-12.4 Visual Analog Scale (mm)
Interval -18.0 to -6.8
|
|
Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale
Change from Baseline to Week 48
|
-18.4 Visual Analog Scale (mm)
Interval -24.0 to -12.8
|
-13.7 Visual Analog Scale (mm)
Interval -20.7 to -6.7
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent To Treat
This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered and takes less than 10 minutes to complete. Study participants will be asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants will respond to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale
Baseline to Week 24
|
-17.7 Visual Analog Scale (mm)
Interval -23.2 to -12.3
|
-13.4 Visual Analog Scale (mm)
Interval -18.2 to -8.5
|
|
Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale
Baseline to Week 48
|
-20.2 Visual Analog Scale (mm)
Interval -26.8 to -13.6
|
-15.0 Visual Analog Scale (mm)
Interval -21.5 to -8.5
|
SECONDARY outcome
Timeframe: Baseline, week 24, week 48Population: Intent to Treat
This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered and takes less than 10 minutes to complete. Study participants will be asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants will respond to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score
Change from Baseline to Week 24
|
-16.3 Visual Analog Scale (mm)
Interval -21.3 to -11.3
|
-12.9 Visual Analog Scale (mm)
Interval -17.9 to -8.0
|
|
Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score
Change from Baseline to Week 48
|
-19.4 Visual Analog Scale (mm)
Interval -25.2 to 13.6
|
-14.4 Visual Analog Scale (mm)
Interval -20.8 to -7.9
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12, 24, 36, and 48-week visitsPopulation: Intent to Treat
Difference between study groups in number of participants who discontinued usage of the study device due to adverse device events at 4, 8, 12, 24, 36, and 48-week visits.
Outcome measures
| Measure |
Sham
n=65 Participants
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 Participants
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Number of Participants Discontinuing the Study Device Due to an Adverse Device Event
|
0 participants
|
0 participants
|
Adverse Events
Sham
PLIUS
Serious adverse events
| Measure |
Sham
n=65 participants at risk
Treatment to index knee with sham device for 48 weeks
Sham Comparator: 20 minutes daily for 48 weeks
|
PLIUS
n=67 participants at risk
Treatment to index knee with PLIUS device for 48 weeks
Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Angina, Unstable
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Gastrointestinal disorders
Ascitis
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
3.0%
2/67 • Number of events 2 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Atrioventricular block, complete
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.1%
2/65 • Number of events 2 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Vascular disorders
Dural arteriovenous fistula
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Skin and subcutaneous tissue disorders
Lipoma
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar radiculopathy
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
3.0%
2/67 • Number of events 2 • Through study completion, an average of 48 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
3.0%
2/67 • Number of events 2 • Through study completion, an average of 48 weeks.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Renal and urinary disorders
Prostatectomy
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Infections and infestations
Prostatitis
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Shoulder arthroplasty
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal laminectomy
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/65 • Through study completion, an average of 48 weeks.
|
1.5%
1/67 • Number of events 1 • Through study completion, an average of 48 weeks.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/65 • Number of events 1 • Through study completion, an average of 48 weeks.
|
0.00%
0/67 • Through study completion, an average of 48 weeks.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place