Trial Outcomes & Findings for Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA) (NCT NCT03469505)
NCT ID: NCT03469505
Last Updated: 2026-06-12
Results Overview
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
764 participants
Primary outcome timeframe
4 months
Results posted on
2026-06-12
Participant Flow
Of the 384 participants randomized to COPES arm, 362 initiated treatment. Of the 380 participants randomized to CBT-CP arm, 249 initiated treatment. All randomized participants were asked to complete all follow up.
Participant milestones
| Measure |
Data From Veterans Using COPES
Data from veterans using COPES for chronic pain
COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
Data from veterans using CBT-CP for chronic pain
CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Overall Study
STARTED
|
384
|
380
|
|
Overall Study
Participants That Initiated Treatment
|
362
|
249
|
|
Overall Study
Completed 4 Month Follow up
|
285
|
298
|
|
Overall Study
Completed 6 Month Follow up
|
267
|
280
|
|
Overall Study
Completed 12 Month Follow-up
|
247
|
276
|
|
Overall Study
Analyzed
|
384
|
380
|
|
Overall Study
COMPLETED
|
247
|
276
|
|
Overall Study
NOT COMPLETED
|
137
|
104
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
Baseline characteristics by cohort
| Measure |
Total
n=764 Participants
Total of all reporting groups
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain
|
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 12.3 • n=267 Participants
|
52.7 years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
53.0 years
STANDARD_DEVIATION 12.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
299 Participants
n=267 Participants
|
150 Participants
n=27 Participants
|
149 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
465 Participants
n=267 Participants
|
230 Participants
n=27 Participants
|
235 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=267 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=267 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=267 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
289 Participants
n=267 Participants
|
150 Participants
n=27 Participants
|
139 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
399 Participants
n=267 Participants
|
190 Participants
n=27 Participants
|
209 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=267 Participants
|
14 Participants
n=27 Participants
|
16 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=267 Participants
|
14 Participants
n=27 Participants
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
107 Participants
n=267 Participants
|
45 Participants
n=27 Participants
|
62 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
656 Participants
n=267 Participants
|
335 Participants
n=27 Participants
|
321 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=267 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=9 Participants
|
|
Brief Pain Inventory-Interference (BPI-I) subscale
|
6.8 pain interference score
STANDARD_DEVIATION 1.8 • n=267 Participants
|
6.8 pain interference score
STANDARD_DEVIATION 1.8 • n=27 Participants
|
6.7 pain interference score
STANDARD_DEVIATION 1.8 • n=9 Participants
|
|
Pain, Enjoyment, General activity scale(PEG)- 3 item
|
6.9 PEG-3 score
STANDARD_DEVIATION 1.6 • n=267 Participants
|
6.9 PEG-3 score
STANDARD_DEVIATION 1.7 • n=27 Participants
|
6.8 PEG-3 score
STANDARD_DEVIATION 1.5 • n=9 Participants
|
|
Patient Health Questionnaire-(PHQ) 8 item
|
16.1 Depression symptom score
STANDARD_DEVIATION 5.8 • n=267 Participants
|
16.3 Depression symptom score
STANDARD_DEVIATION 5.8 • n=27 Participants
|
15.9 Depression symptom score
STANDARD_DEVIATION 5.8 • n=9 Participants
|
|
Pain Catastrophizing Scale, Short Form (PCS-SF)
|
11.0 Catastrophizing thinking score
STANDARD_DEVIATION 3.0 • n=267 Participants
|
11.1 Catastrophizing thinking score
STANDARD_DEVIATION 3.0 • n=27 Participants
|
10.9 Catastrophizing thinking score
STANDARD_DEVIATION 3.0 • n=9 Participants
|
|
Insomnia Severity Index (ISI)
|
20.5 sleep hygiene symptom score
STANDARD_DEVIATION 5.8 • n=267 Participants
|
20.6 sleep hygiene symptom score
STANDARD_DEVIATION 6.0 • n=27 Participants
|
20.5 sleep hygiene symptom score
STANDARD_DEVIATION 5.6 • n=9 Participants
|
|
Pain Self-Efficacy Questionnaire, Short Form (PSEQ-SF)
|
4.2 pain self-efficacy score
STANDARD_DEVIATION 2.6 • n=267 Participants
|
4.2 pain self-efficacy score
STANDARD_DEVIATION 2.7 • n=27 Participants
|
4.2 pain self-efficacy score
STANDARD_DEVIATION 2.5 • n=9 Participants
|
|
Numeric Rating Scale (NRS), Pain Intensity
|
6.7 pain score
STANDARD_DEVIATION 1.5 • n=267 Participants
|
6.7 pain score
STANDARD_DEVIATION 1.6 • n=27 Participants
|
6.7 pain score
STANDARD_DEVIATION 1.4 • n=9 Participants
|
|
Study Site
Site 1
|
38 Participants
n=267 Participants
|
18 Participants
n=27 Participants
|
20 Participants
n=9 Participants
|
|
Study Site
Site 2
|
34 Participants
n=267 Participants
|
16 Participants
n=27 Participants
|
18 Participants
n=9 Participants
|
|
Study Site
Site 3
|
49 Participants
n=267 Participants
|
25 Participants
n=27 Participants
|
24 Participants
n=9 Participants
|
|
Study Site
Site 4
|
391 Participants
n=267 Participants
|
195 Participants
n=27 Participants
|
196 Participants
n=9 Participants
|
|
Study Site
Site 5
|
49 Participants
n=267 Participants
|
25 Participants
n=27 Participants
|
24 Participants
n=9 Participants
|
|
Study Site
Site 6
|
20 Participants
n=267 Participants
|
11 Participants
n=27 Participants
|
9 Participants
n=9 Participants
|
|
Study Site
Site 7
|
21 Participants
n=267 Participants
|
10 Participants
n=27 Participants
|
11 Participants
n=9 Participants
|
|
Study Site
Site 8
|
57 Participants
n=267 Participants
|
28 Participants
n=27 Participants
|
29 Participants
n=9 Participants
|
|
Study Site
Site 9
|
105 Participants
n=267 Participants
|
52 Participants
n=27 Participants
|
53 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
|
5.26 score on a scale
Standard Error 0.15
|
6.23 score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
|
5.17 score on a scale
Standard Error 0.15
|
5.57 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
|
5.65 score on a scale
Standard Error 0.16
|
6.39 score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 4 monthPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
The PEG-3 is a three-Item Scale Assessing Pain Intensity and Interference. Data was collected through automated IVR calls with a range from 0-10. Higher scores indicate more pain impact (intensity and interference).
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score
|
5.28 score on a scale
Standard Error 0.14 • Interval -1.37 to -0.67
|
6.3 score on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
PHQ-8 is a Depression symptom severity scale will be assessed using the 8-item a widely-used measure with excellent internal consistency and stability.PHQ-8 score range is 0-24; ≥10 indicates clinically significant depressive symptoms. Higher scores indicate more depressive symptomatology.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Patient Health Questionnaire (PHQ-8) Score
|
13.54 score on a scale
Standard Error 0.44 • Interval -2.93 to -0.95
|
15.49 score on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
The Pain Catastrophizing Scale (PCS)-Short Form is a validated, 3-item self-report scale that examines thoughts and feelings people may experience when they are in pain. Total score range 3-15 with higher scores indicating more catatrophizing.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Pain Catastrophizing Scale (PCS)- Short Form
|
8.6 score on a scale
Standard Error 0.26
|
10.18 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
Sleep quality was measured using the ISI and will assess subjective sleep quality. ISI score range 0-28, higher scores indicate higher sleep difficulty, (15 or above clinical insomnia).
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Insomnia Severity Index (ISI) Score
|
17.62 score on a scale
Standard Error 0.43 • Interval -3.17 to -1.28
|
19.85 score on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
Self-Efficacy will be assessed using 1-Item of the PSEQ.PSEQ score range 0- 10. Higher scores indicate higher pain self-efficacy.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Pain Self-Efficacy Questionnaire (PSEQ) Score
|
5.88 score on a scale
Standard Error 0.19 • Interval 0.75 to 1.76
|
4.63 score on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 4 monthsThe Patient Global Perception of Change scale is a single item measure that quantifies a participant's overall perception of improvement since beginning treatment and the clinical importance of that improvement. Participants indicate improvement on a 1-7s scale with 1 as "much worse" to "much better" scale. For PGIC (ordinal) data repored is number of participants with at least moderate improvement (score\>=5).
Outcome measures
| Measure |
Data From Veterans Using COPES
n=285 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=297 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Patient Global Perception of Change (PGIC)
|
130 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: 4 monthPopulation: Data presented here is from those who completed the 4 month assessment.
Pain satisfaction will be measured using an adapted Pain Satisfaction Questionnaire. This 5-item measure about patient self report of experience of treatment . The questions are on a scale from (0=very dissatisfied to 4=very satisfied). Total score range 0-4 with higher scores indicating more satisfaction.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=282 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=292 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Pain Satisfaction Questionnaire Score
|
2.91 score on a scale
Standard Error 0.1 • Interval 0.26 to 0.74
|
2.41 score on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Up to 12 months post baselinePopulation: Those participants who initiated treatment in each condition.
Number of cognitive behavioral therapy for chronic pain sessions or COPES sessions attended for this treatment. Data presented is the number of sessions completed by expected number of sessions, among participants who initiated treatment.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=362 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=249 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Difference in Treatment Dose
|
100 percentage of expected sessions
Interval 73.0 to 100.0
|
83 percentage of expected sessions
Interval 27.0 to 100.0
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: This is an intent to treat analysis with all randomized participants being analyzed.
Average pain intensity NRS rating (over past week) range is 0-10. Higher scores indicate more pain.
Outcome measures
| Measure |
Data From Veterans Using COPES
n=384 Participants
Data from veterans using COPES for chronic pain COPES: Cooperative Pain Education and Self-Management for chronic pain therapy.
|
Data From Veterans Using CBT-CP
n=380 Participants
Data from veterans using CBT-CP for chronic pain CBT-CP: Cognitive Behavioral Therapy for Chronic Pain
|
|---|---|---|
|
Mean Numeric Rating Score (NRS), Pain Intensity Score
|
5.53 score on a scale
Standard Error 0.14 • Interval -1.02 to -0.39
|
6.24 score on a scale
Standard Error 0.11
|
Adverse Events
Data From Veterans Using COPES
Serious events: 31 serious events
Other events: 0 other events
Deaths: 2 deaths
Data From Veterans Using CBT-CP
Serious events: 49 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Data From Veterans Using COPES
n=384 participants at risk
Data from veterans using COPES for chronic pain
|
Data From Veterans Using CBT-CP
n=380 participants at risk
Data from veterans using CBT-CP for chronic pain
|
|---|---|---|
|
Gastrointestinal disorders
Hip Arthroplasty and Small Bowel Obstruction complications
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Gastrointestinal disorders
Hospital Admission for Blood in Vomit and Stool
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Hospital Admission for Chest Pain and Shortness of Breath
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Eye disorders
Hospitalization for Eye conditions
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Psychiatric disorders
Hospitalization-mental &social health
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Infections and infestations
Infections and toe amputation
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Psychiatric disorders
Inpatient Admission for Psychiatric Monitoring
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
General disorders
Inpatient Alcohol Detox
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
General disorders
Inpatient at hospital through 9/26 then transferred to CLC
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Inpatient following hernia procedure
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Nervous system disorders
Inpatient hand trembling
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Inpatient Hospital Stay for continued cardiac issues
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Psychiatric disorders
In-patient psychiatric hospitalization due to auditory hallucinations
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Knee Arthroplasty and Recovery
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Knee Replacement
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Laparoscopic surgery-hemicolectomy
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Eye disorders
Left Eye Amaurosis Fugax
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Liver Resection
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Nervous system disorders
Loss of Consciousness while driving
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Low blood Pressure
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Lower abdominal wall panniculectomy
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower Extremity Pain and Cardiac/Neurological concerns
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Lumbar interbody fusion-posterior
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
General disorders
Nausea & Chest pain
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Nervous system disorders
Neuro Work Up after previous inpatient stay
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Nervous system disorders
Neurological Investigation for Fall and Weakness
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain all over
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pancreatitis and Pneumonia
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Infections and infestations
Pancreatitis
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Endocrine disorders
Pancreatitus and Cholecystectomy
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Gastrointestinal disorders
Persistent Heartburn
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Psychiatric disorders
Psychiatric Admission for SI
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Renal and urinary disorders
Renal Biopsy and Bleeding
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Renal mass nephrectomy
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Right Toe Amputation and Sustained hospitalization for infection
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
General disorders
Sepsis/Septic Shock risk and admitted to inpatient
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Septoplasty
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Shortness of Breath, Inpatient observation
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Gastrointestinal disorders
Small Bowel Obstructions and Hospitalization Stay
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Spine Fusion
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Psychiatric disorders
Suicidal Ideation and hospitalization
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Nervous system disorders
Sustained Aphasia
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Renal and urinary disorders
Swelling and Admitted for monitoring of Kidney issues
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Infections and infestations
Swollen Foot and Infection
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
General disorders
Tachycardic and confusion symptoms
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Infections and infestations
Toe Wound Infection
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Renal and urinary disorders
UTI & Fibromyalgia sx
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
General disorders
Vomiting, abdominal pain, headache, nausea
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
General disorders
Weakness and Rectal Bleeding
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Chest and Back Pain
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Chest Pain and Cardiac Concerns
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Chest Pain and Gall Bladder Surgery
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Chest pain and headache
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Chest Pain and high blood pressure
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Chest Pain and Panic Attack/Distress
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Chest Pain and Shortness of Breath
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Chest Pain, shortness of breath and other symptoms
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Chest Pain/Heart Issues
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Endocrine disorders
Cholecystectomy/ Pancreatitis
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Cholecystitis with gangrene
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Vascular disorders
Coronary Artery Disease
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID and Hospitalization
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID Hospitalization
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Hernia Repair
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Hernia Repair surgery
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Skin and subcutaneous tissue disorders
HIDRADENITIS SUPPURATIVA
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
High Blood Pressure and Inpatient Admission
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID Positive with COVID Pneumonia
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID-related Hospitalization
|
0.26%
1/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Nervous system disorders
Epilepsy-Seizure/neurological symptoms
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
General disorders
Extended Hospital Stay, Foot wound, ICU Stay through Aug-sept
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Injury, poisoning and procedural complications
Fall down stairs, broken wrist and surgery
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Injury, poisoning and procedural complications
Fractured Femurs and Pelvis
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Gastrectomy
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
General disorders
General hospitalization
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Gastrointestinal disorders
GERD Surgery
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Infections and infestations
Hand infection
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Injury, poisoning and procedural complications
Head Injury and transferred to ICU; Stroke Diagnosis
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Heart Palpitations
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain and Fever
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain, Acute Appendicitis, Surgery and Follow Up
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain, Diarrhea, Vomit
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Psychiatric disorders
Admission for Sleep Stabilization
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Cardiac disorders
Afib following cardiac ablation
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Ankle Arthroplasty
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Appendectomy
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Surgical and medical procedures
Appendicitis and Surgery
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arm, Knee, and back pain
|
0.00%
0/384 • 12 months
|
0.26%
1/380 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain Flare hospital stay
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Injury, poisoning and procedural complications
Broken Right Ankle and Ongoing Dizziness; Surgery
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Surgical and medical procedures
Buttocks Abscess and Diarrhea
|
0.26%
1/384 • 12 months
|
0.00%
0/380 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/384 • 12 months
|
0.53%
2/380 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place