Trial Outcomes & Findings for Pain Coping Skills Training for African Americans With Osteoarthritis (NCT NCT02560922)
NCT ID: NCT02560922
Last Updated: 2019-04-01
Results Overview
Change over time in the primary outcome measure for this study, the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with a total range of 0-20 with higher scores indicating worse symptoms and function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
Baseline, 3 months and 9 months
Results posted on
2019-04-01
Participant Flow
Participant milestones
| Measure |
Pain Coping Skills Training
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
|
Overall Study
COMPLETED
|
98
|
112
|
|
Overall Study
NOT COMPLETED
|
26
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Coping Skills Training for African Americans With Osteoarthritis
Baseline characteristics by cohort
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Some education above high school
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Working
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Married or living with partner
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Low Perceived Income
|
48 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
35.6 kg/m²
STANDARD_DEVIATION 8.4 • n=5 Participants
|
34.8 kg/m²
STANDARD_DEVIATION 7.9 • n=7 Participants
|
35.2 kg/m²
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Number of Self-Reported Comorbidities
|
8.2 comorbidities
STANDARD_DEVIATION 3.9 • n=5 Participants
|
8.8 comorbidities
STANDARD_DEVIATION 4.0 • n=7 Participants
|
8.5 comorbidities
STANDARD_DEVIATION 3.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
Change over time in the primary outcome measure for this study, the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with a total range of 0-20 with higher scores indicating worse symptoms and function.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Baseline to 3 month change
|
-1.59 units on a scale
Interval -2.21 to -0.97
|
-0.96 units on a scale
Interval -1.56 to -0.35
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
Baseline to 9 month change
|
-2.24 units on a scale
Interval -2.91 to -1.56
|
-1.40 units on a scale
Interval -2.04 to -0.77
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
In addition to the pain subscale, the WOMAC includes stiffness (2 items) and function (17 items) subscales. All items are listed rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with ranges of 0-96 for the total score (pain, stiffness, and function subscales), with higher scores indicating worse symptoms and function.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Baseline to 3 month change
|
-6.60 units on a scale
Interval -9.1 to -4.1
|
-3.98 units on a scale
Interval -6.42 to -1.55
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
Baseline to 9 month change
|
-8.81 units on a scale
Interval -11.58 to -6.05
|
-5.50 units on a scale
Interval -8.11 to -2.89
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
In addition to the pain subscale, the WOMAC includes stiffness (2 items) and function (17 items) subscales. All items are listed rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with ranges of 0-68 for the function subscale, with higher scores indicating worse symptoms and function.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Baseline to 3 month change
|
-4.08 units on a scale
Interval -5.93 to -2.22
|
-2.46 units on a scale
Interval -4.27 to -0.65
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
Baseline to 9 month change
|
-5.60 units on a scale
Interval -7.69 to -3.51
|
-3.41 units on a scale
Interval -5.39 to -1.43
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
The PROMIS Pain Interference (Short Form 6a) instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher scores indicate greater pain interference.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a)
Baseline to 3 month change in t-score
|
-2.63 t-score
Interval -3.66 to -1.6
|
-1.80 t-score
Interval -2.8 to -0.8
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a)
Baseline to 9 month change in t-score
|
-2.75 t-score
Interval -3.83 to -1.67
|
-1.61 t-score
Interval -2.63 to -0.6
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
This 12-item measure covers domains of general health, physical health, work and activity limitations, and emotional health. Mental Health and Physical Health Composite Scores were computed, both of which range from 0-100 with lower scores indicating poorer health.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score
Baseline to 3 month change
|
2.60 units on a scale
Interval 1.05 to 4.15
|
0.89 units on a scale
Interval -0.63 to 2.4
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score
Baseline to 9 month change
|
2.47 units on a scale
Interval 0.86 to 4.08
|
1.74 units on a scale
Interval 0.21 to 3.26
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: This variable was analyzed as a change score (baseline to 3-month and baseline to 9-month), due to normality assumptions. Therefore only participants with complete data at baseline and follow-up could be included in the analysis, resulting in a smaller sample than the total population.
This 12-item measure covers domains of general health, physical health, work and activity limitations, and emotional health. Mental Health and Physical Health Composite Scores were computed, both of which range from 0-100 with lower scores indicating poorer health.
Outcome measures
| Measure |
Pain Coping Skills Training
n=117 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=112 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score
Baseline to 3 month change
|
-0.72 units on a scale
Interval -2.08 to 0.64
|
-1.48 units on a scale
Interval -2.82 to -0.15
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score
Baseline to 9 month change
|
-0.57 units on a scale
Interval -2.13 to 0.99
|
-2.28 units on a scale
Interval -3.77 to -0.79
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 9 monthsPopulation: All randomized participants
This scale includes 48 items that assess 6 cognitive domains (Catastrophizing, Diverting Attention, Ignoring Sensations, Coping Self-Statements, Reinterpreting Pain Sensations, Praying-Hoping) and 1 behavioral domain (Increasing Behavioral Activities). Each domain includes 6 items, and participants rate the frequency of their use of specific coping strategies on a 7-point Likert scale from 0 ("Never do that") to 6 ("Always do that"). A Total Coping Attempts score was created, which includes 5 cognitive domains and 1 behavioral domain but excludes the Catastrophizing domain, similar to prior studies. Total range is 252, with higher scores indicating more coping attempts.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ)
Baseline to 3 month change
|
16.46 units on a scale
Interval 11.68 to 21.25
|
1.15 units on a scale
Interval -3.52 to 5.83
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ)
Baseline to 9 month change
|
9.27 units on a scale
Interval 4.26 to 14.28
|
-2.40 units on a scale
Interval -7.18 to 2.37
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
This 8-item survey of depressive symptoms includes items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV) \[38\]. All items are scored as 0 (not at all) to 3 (nearly every day), with higher scores indicating more depressive symptoms.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8)
Baseline to 3 month change
|
-0.32 units on a scale
Interval -1.12 to 0.48
|
0.18 units on a scale
Interval -0.59 to 0.96
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8)
Baseline to 9 month change
|
-0.89 units on a scale
Interval -1.78 to 0.0
|
0.13 units on a scale
Interval -0.71 to 0.97
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
This scale includes 8 items asking respondents how certain they are that they can manage arthritis pain and keep it from interfering with specific activities All items are scored on a scale of 1 (very uncertain) to 10 (very certain), with higher scores indicating greater self-efficacy for managing arthritis symptoms.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale
Baseline to 9 month change
|
0.46 units on a scale
Interval 0.14 to 0.78
|
-0.21 units on a scale
Interval -0.51 to 0.1
|
|
Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale
Baseline to 3 month change
|
0.81 units on a scale
Interval 0.5 to 1.11
|
-0.20 units on a scale
Interval -0.5 to 0.09
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 9 monthsPopulation: All randomized participants
This measure asks participants to describe their change in pain on a 7-point rating scale with the following options: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse." The total range is 0-7, with lower scores indicating more improvement.
Outcome measures
| Measure |
Pain Coping Skills Training
n=124 Participants
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 Participants
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months
Self reported change in symptoms between BL and 3m
|
2.91 units on a scale
Interval 2.67 to 3.14
|
4.18 units on a scale
Interval 3.95 to 4.4
|
|
Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months
Self reported change in symptoms between BL and 9m
|
3.25 units on a scale
Interval 2.99 to 3.52
|
4.13 units on a scale
Interval 3.87 to 4.38
|
Adverse Events
Pain Coping Skills Training
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pain Coping Skills Training
n=124 participants at risk
This group will take part in an 11-week pain coping skills training (CST) intervention.
Pain Coping Skills Training (CST): The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
|
Wait List Control
n=124 participants at risk
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.
|
|---|---|---|
|
Gastrointestinal disorders
lower GI bleed
|
1.6%
2/124 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Cardiac disorders
Chest Pain
|
1.6%
2/124 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.
|
1.6%
2/124 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Cardiac disorders
Congestive Heart Failure
|
1.6%
2/124 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Total knee arthroplasty of right knee
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Laparoscopic Gastrocutaneous Fistula Takedown
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Surgical removal of lymphedema lobe on left leg
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Injury, poisoning and procedural complications
Accidental exposure to trichoroacetic acid
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Injury, poisoning and procedural complications
Food impaction in esophagus
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Injury, poisoning and procedural complications
Fractured ribs
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
1.6%
2/124 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia and dyspnea
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Surgical and medical procedures
Implantation of catheter-delivered aortic heart valve, insertion of temporary pacemaker, introductio
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Infections and infestations
Sepsis 2/2 Abdominal cellulitis
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/124 • Data were collected for 12 months, ending at participants' final follow up time point.
|
0.81%
1/124 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.
|
Other adverse events
Adverse event data not reported
Additional Information
Kelli D. Allen, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-0558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place