Trial Outcomes & Findings for Phone-Based Based Walk With Ease Program for Adults With Arthritis (NCT NCT05289544)
NCT ID: NCT05289544
Last Updated: 2026-03-06
Results Overview
Visual analog scale (0mm no/low pain to 100 mm high pain)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
267 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
Phone Based Walk With Ease
6 week phone-based Walk With Ease starting immediately after randomization
|
Delayed Phone Based Walk With Ease
6 week phone based Walk With Ease starting 12 months after randomization
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
135
|
|
Overall Study
COMPLETED
|
109
|
115
|
|
Overall Study
NOT COMPLETED
|
23
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phone-Based Based Walk With Ease Program for Adults With Arthritis
Baseline characteristics by cohort
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.06 years
STANDARD_DEVIATION 9.38 • n=41 Participants
|
64.13 years
STANDARD_DEVIATION 9.36 • n=35 Participants
|
64.1 years
STANDARD_DEVIATION 9.4 • n=76 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=41 Participants
|
123 Participants
n=35 Participants
|
245 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
22 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
160 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=41 Participants
|
52 Participants
n=35 Participants
|
98 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=76 Participants
|
|
Actigraph Measured moderate-vigorous intensity physical activity
|
51.32 minutes/week
STANDARD_DEVIATION 10.36 • n=41 Participants
|
54.83 minutes/week
STANDARD_DEVIATION 11.24 • n=35 Participants
|
53.08 minutes/week
STANDARD_DEVIATION 10.8 • n=76 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksVisual analog scale (0mm no/low pain to 100 mm high pain)
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Pain
|
-4.0 score on a scale
Interval -11.3 to 3.3
|
-4.49 score on a scale
Interval -11.59 to 2.6
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsVisual analog scale (0mm no/low pain to 100 mm high pain)
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Pain
|
-1.04 score on a scale
Interval -8.99 to 6.92
|
0.35 score on a scale
Interval -7.05 to 7.76
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsVisual analog scale (0mm no/low pain to 100 mm high pain)
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Pain
|
-5.02 score on a scale
Interval -13.87 to 3.83
|
-4.89 score on a scale
Interval -12.71 to 2.93
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksrepetitions completed during 30 second chair stand test
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Function - Chair Stands
|
0.98 repetitions
Interval 0.43 to 1.52
|
0.48 repetitions
Interval -0.08 to 1.04
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsrepetitions completed during 30 second chair stand test
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Function - Chair Stands
|
1.0 repetitions
Interval 0.33 to 1.67
|
0.69 repetitions
Interval 0.12 to 1.25
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsrepetitions completed during 30 second chair stand test
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Function - Chair Stands
|
0.79 repetitions
Interval 0.13 to 1.45
|
0.45 repetitions
Interval -0.16 to 1.06
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksDistance walked (ft) during 6 minute walk test
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Function - 6 Minute Walk
|
17.66 feet
Interval -21.53 to 56.86
|
-10.15 feet
Interval -48.3 to 27.99
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsDistance walked (ft) during 6 minute walk test
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Function - 6 Minute Walk
|
-27.33 feet
Interval -79.66 to 25.01
|
0.24 feet
Interval -40.64 to 41.12
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsDistance walked (ft) during 6 minute walk test
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Function - 6 Minute Walk
|
-21.32 feet
Interval -76.3 to 33.67
|
2.19 feet
Interval -40.78 to 45.16
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksHealth Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Limitations
|
-0.09 score on a scale
Interval -0.15 to -0.04
|
-0.05 score on a scale
Interval -0.12 to 0.01
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsHealth Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Limitations
|
-0.05 score on a scale
Interval -0.12 to 0.01
|
-0.02 score on a scale
Interval -0.1 to 0.05
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsHealth Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Limitations
|
-0.06 score on a scale
Interval -0.12 to 0.01
|
-0.02 score on a scale
Interval -0.08 to 0.04
|
SECONDARY outcome
Timeframe: Baseline to 6 weekstotal moderate and vigorous intensity physical activity (\>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Activity
|
0.10 log(activity minutes)
Interval -0.18 to 0.38
|
-0.08 log(activity minutes)
Interval -0.37 to 0.21
|
SECONDARY outcome
Timeframe: Baseline to 6 monthstotal moderate and vigorous intensity physical activity (\>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Activity
|
-0.15 log(activity minutes)
Interval -0.44 to 0.14
|
0.03 log(activity minutes)
Interval -0.3 to 0.36
|
SECONDARY outcome
Timeframe: Baseline to 12 monthstotal moderate and vigorous intensity physical activity (\>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Physical Activity
|
-0.16 log(activity minutes)
Interval -0.62 to 0.0
|
-0.01 log(activity minutes)
Interval -0.32 to 0.29
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksConfidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Arthritis Management Self-efficacy
|
1.55 score on a scale
Interval 0.93 to 2.17
|
0.49 score on a scale
Interval -0.11 to 1.14
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsConfidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Arthritis Management Self-efficacy
|
1.17 score on a scale
Interval 0.55 to 1.8
|
0.52 score on a scale
Interval -0.1 to 1.14
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsConfidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Arthritis Management Self-efficacy
|
1.42 score on a scale
Interval 0.73 to 2.11
|
0.65 score on a scale
Interval -0.04 to 1.34
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksDiastolic blood pressure measured in mmHg
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Blood Pressure
|
-0.46 mmHg
Interval -3.01 to 2.1
|
-0.23 mmHg
Interval -2.81 to 2.35
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsDiastolic blood pressure measured in mmHg
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Blood Pressure
|
-0.67 mmHg
Interval -3.37 to 2.02
|
-1.16 mmHg
Interval -3.84 to 1.52
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsDiastolic blood pressure measured in mmHg
Outcome measures
| Measure |
Phone-Based Walk With Ease Program
n=132 Participants
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
|
Delayed Phone-Based Walk With Ease Program
n=135 Participants
Telephone-Based Walk With Ease Program starting after the 1 year assessment
|
|---|---|---|
|
Change in Blood Pressure
|
-2.52 mmHg
Interval -5.62 to 0.57
|
-0.40 mmHg
Interval -3.21 to 2.41
|
Adverse Events
Phone-Based Walk With Ease Program
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Delayed Phone-Based Walk With Ease Program
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phone-Based Walk With Ease Program
n=132 participants at risk
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
Phone-Based Walk With Ease: 6 week phone-delivered Walk With Ease Program
|
Delayed Phone-Based Walk With Ease Program
n=135 participants at risk
Telephone-Based Walk With Ease Program starting after the 1 year assessment
Phone-Based Walk With Ease: 6 week phone-delivered Walk With Ease Program
|
|---|---|---|
|
Vascular disorders
stroke
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Cardiac disorders
Aortic stenosis
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain surgery to remove tumor
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
Other adverse events
| Measure |
Phone-Based Walk With Ease Program
n=132 participants at risk
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
Phone-Based Walk With Ease: 6 week phone-delivered Walk With Ease Program
|
Delayed Phone-Based Walk With Ease Program
n=135 participants at risk
Telephone-Based Walk With Ease Program starting after the 1 year assessment
Phone-Based Walk With Ease: 6 week phone-delivered Walk With Ease Program
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Hamstring injury
|
0.00%
0/132 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.74%
1/135 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Skin and subcutaneous tissue disorders
skin abrasions
|
1.5%
2/132 • Number of events 2 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Eye disorders
Eye injury/surgery
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.74%
1/135 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Cardiac disorders
Heart condition or procedure
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
1.5%
2/135 • Number of events 3 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Gastrointestinal disorders
Gastrointestinal related diagnosis
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
1.5%
2/135 • Number of events 2 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Nervous system disorders
Aphasia
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer or related surgery
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.74%
1/135 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Reproductive system and breast disorders
Hysterectomy
|
0.00%
0/132 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.74%
1/135 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Endocrine disorders
Elevated blood glucose
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Nervous system disorders
Parkinsons disease diagnosis
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/132 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.74%
1/135 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
General disorders
Lightheadedness
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Knee injury/swelling
|
4.5%
6/132 • Number of events 6 • 12 months
adverse events reported during the study including events unrelated to the study
|
3.7%
5/135 • Number of events 5 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Nervous system disorders
mini stroke
|
0.76%
1/132 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Fall
|
4.5%
6/132 • Number of events 7 • 12 months
adverse events reported during the study including events unrelated to the study
|
3.0%
4/135 • Number of events 4 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Knee replacement
|
2.3%
3/132 • Number of events 3 • 12 months
adverse events reported during the study including events unrelated to the study
|
2.2%
3/135 • Number of events 3 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Back injury/issue
|
5.3%
7/132 • Number of events 8 • 12 months
adverse events reported during the study including events unrelated to the study
|
1.5%
2/135 • Number of events 2 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Foot or ankle injury
|
2.3%
3/132 • Number of events 3 • 12 months
adverse events reported during the study including events unrelated to the study
|
5.2%
7/135 • Number of events 8 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Shoulder injury or surgery
|
1.5%
2/132 • Number of events 2 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.74%
1/135 • Number of events 1 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Injury, poisoning and procedural complications
car accident
|
3.0%
4/132 • Number of events 4 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Musculoskeletal and connective tissue disorders
Hip injury or surgery
|
2.3%
3/132 • Number of events 3 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
|
Nervous system disorders
Seizure
|
1.5%
2/132 • Number of events 2 • 12 months
adverse events reported during the study including events unrelated to the study
|
0.00%
0/135 • 12 months
adverse events reported during the study including events unrelated to the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place