Trial Outcomes & Findings for Case Managers for CVD Risk Reduction in HIV Clinic (NCT NCT03839394)
NCT ID: NCT03839394
Last Updated: 2024-09-24
Results Overview
Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve \>5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline, 24 weeks, 48 weeks, 72 weeks
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
Educational Pamphlets + Telephone
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
19
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
Educational Pamphlets + Telephone
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Case Managers for CVD Risk Reduction in HIV Clinic
Baseline characteristics by cohort
| Measure |
Educational Pamphlets + Telephone
n=25 Participants
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=24 Participants
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeksPopulation: Participants with data collected at both timepoints.
Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve \>5mmHg reduction in systolic blood pressure from baseline. Reported here is the change from baseline to 72 weeks.
Outcome measures
| Measure |
Educational Pamphlets + Telephone
n=19 Participants
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=14 Participants
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Change in Ambulatory Systolic Blood Pressure
|
1.9 mmHg
Standard Deviation 15.0
|
-10.7 mmHg
Standard Deviation 10.9
|
PRIMARY outcome
Timeframe: Baseline, 72 weeksPopulation: Participants with data collected at both timepoints.
Outcome measures
| Measure |
Educational Pamphlets + Telephone
n=19 Participants
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=14 Participants
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline
|
7 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeksPopulation: Participants with data collected at both timepoints.
Assessment of the absolute change in fasting calculated non-high density lipoprotein cholesterol over the study period. Reported here is the change from baseline to 72 weeks.
Outcome measures
| Measure |
Educational Pamphlets + Telephone
n=16 Participants
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=15 Participants
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels
|
-5.7 mg/dL
Standard Deviation 36.2
|
-1.5 mg/dL
Standard Deviation 37.4
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeksPopulation: Participants with data collected at both timepoints.
Total change in body weight from baseline over the study period. Reported here is the change from baseline to 72 weeks.
Outcome measures
| Measure |
Educational Pamphlets + Telephone
n=19 Participants
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=14 Participants
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Total Change in Body Weight
|
-1.8 kg
Standard Deviation 5.1
|
-2.1 kg
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 48 weeks, 72 weeksPopulation: Participants with data collected at both timepoints.
The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator. The ASCVD risk score is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. The ASCVD risk score is given as a percentage, which represents the chance of having heart disease or stroke in the next 10 years. 0 to 4.9 = low risk, 5 to 7.4 = borderline risk, 7.5 to 20 = intermediate risk, \>20 = high risk. Reported here is the change from baseline to 72 weeks.
Outcome measures
| Measure |
Educational Pamphlets + Telephone
n=12 Participants
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=6 Participants
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score
|
-1.0 percentage of risk
Standard Deviation 4.1
|
-0.4 percentage of risk
Standard Deviation 3.3
|
Adverse Events
Educational Pamphlets + Telephone
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Educational Pamphlets
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Educational Pamphlets + Telephone
n=25 participants at risk
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=24 participants at risk
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Gastrointestinal disorders
incarcerated inguinal hernia
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
4.2%
1/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Blood and lymphatic system disorders
deep venous thrombosis
|
0.00%
0/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
4.2%
1/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Reproductive system and breast disorders
epididimytis
|
0.00%
0/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
4.2%
1/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Nervous system disorders
stroke
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Psychiatric disorders
suicidal ideation
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Psychiatric disorders
auditory hallucinations
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Musculoskeletal and connective tissue disorders
rhabdomyolysis
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Gastrointestinal disorders
gastroenteritis
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Gastrointestinal disorders
colonic polyps
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Gastrointestinal disorders
esophageal mass
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Cardiac disorders
syncope
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
Other adverse events
| Measure |
Educational Pamphlets + Telephone
n=25 participants at risk
Telephone: A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
Educational Pamphlets
n=24 participants at risk
Educational pamphlets: A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
|
|---|---|---|
|
Surgical and medical procedures
cataract surgery
|
0.00%
0/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
4.2%
1/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Social circumstances
assault
|
0.00%
0/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
4.2%
1/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Gastrointestinal disorders
anal condyloma
|
0.00%
0/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
4.2%
1/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Surgical and medical procedures
colonoscopy
|
8.0%
2/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Surgical and medical procedures
direct laryngoscopy
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Surgical and medical procedures
upper endoscopy
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Respiratory, thoracic and mediastinal disorders
laryngeal mass
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Surgical and medical procedures
hip replacement
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Infections and infestations
COVID-19
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Infections and infestations
gonorrhea
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Infections and infestations
scapular abscess
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Surgical and medical procedures
transurethral prostatectomy
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
|
Gastrointestinal disorders
inguinal hernia
|
4.0%
1/25 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
0.00%
0/24 • Up to 72 weeks
All significant medical events reported in all participants during the study observation period were abstracted from the clinical record, recorded in the study record and adjudicated for association with study intervention by the study PI.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place