Trial Outcomes & Findings for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (NCT NCT00781365)
NCT ID: NCT00781365
Last Updated: 2017-04-13
Results Overview
Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
Baseline, 6 months, 12 months, 18 months
Results posted on
2017-04-13
Participant Flow
Recruitment was between March 2009-April 2011. We identified adult patients with elevated BP (systolic BP \>140 or diastolic BP \>90 mm Hg) at the two most recent primary care visits in the past year using electronic medical records. Patients received up to two mailings followed by phone calls. Further screening occurred in research clinic.
Participants were assigned to treatment group based on their primary care clinic location. Clinics were randomized to treatment or control (cluster randomization).
Participant milestones
| Measure |
Telemonitoring Intervention
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
Usual Care
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
222
|
|
Overall Study
COMPLETED
|
194
|
186
|
|
Overall Study
NOT COMPLETED
|
34
|
36
|
Reasons for withdrawal
| Measure |
Telemonitoring Intervention
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
Usual Care
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
8
|
|
Overall Study
Did Not Attend Visit
|
20
|
28
|
|
Overall Study
Language barrier
|
1
|
0
|
Baseline Characteristics
Home Blood Pressure Telemonitoring and Case Management to Control Hypertension
Baseline characteristics by cohort
| Measure |
Usual Care
n=222 Participants
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
Telemonitoring Intervention
n=228 Participants
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
152 Participants
n=93 Participants
|
147 Participants
n=4 Participants
|
299 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
70 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
62.0 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
201 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
213 Participants
n=93 Participants
|
227 Participants
n=4 Participants
|
440 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
177 participants
n=93 Participants
|
191 participants
n=4 Participants
|
368 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
29 participants
n=93 Participants
|
24 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 participants
n=93 Participants
|
9 participants
n=4 Participants
|
22 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 monthsPercentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
Outcome measures
| Measure |
Usual Care
n=222 Participants
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
Telemonitoring Intervention
n=228 Participants
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
|---|---|---|
|
Blood Pressure Control
Baseline
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Blood Pressure Control
6 Months
|
45.2 percentage of participants
Interval 39.2 to 51.3
|
71.8 percentage of participants
Interval 65.6 to 77.3
|
|
Blood Pressure Control
12 Months
|
52.8 percentage of participants
Interval 45.4 to 60.2
|
71.2 percentage of participants
Interval 62.0 to 78.9
|
|
Blood Pressure Control
18 Months
|
57.1 percentage of participants
Interval 51.5 to 62.6
|
71.8 percentage of participants
Interval 65.0 to 77.8
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 54 monthsSystolic blood pressure at baseline and 4 time points
Outcome measures
| Measure |
Usual Care
n=222 Participants
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
Telemonitoring Intervention
n=228 Participants
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
|---|---|---|
|
Mean Systolic Blood Pressure
Baseline
|
147.7 mmHg
Interval 145.8 to 149.5
|
148.2 mmHg
Interval 146.3 to 150.0
|
|
Mean Systolic Blood Pressure
6 Months
|
136.9 mmHg
Interval 134.6 to 139.2
|
126.7 mmHg
Interval 124.4 to 129.0
|
|
Mean Systolic Blood Pressure
12 Months
|
134.8 mmHg
Interval 132.5 to 137.2
|
125.7 mmHg
Interval 123.4 to 128.0
|
|
Mean Systolic Blood Pressure
18 Months
|
133.0 mmHg
Interval 130.4 to 135.5
|
126.9 mmHg
Interval 124.3 to 129.4
|
|
Mean Systolic Blood Pressure
54 Months
|
131.7 mmHg
Interval 128.8 to 134.6
|
131.2 mmHg
Interval 128.3 to 134.1
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 54 monthsMean diastolic blood pressure at baseline and 4 time points
Outcome measures
| Measure |
Usual Care
n=222 Participants
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
Telemonitoring Intervention
n=228 Participants
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
|---|---|---|
|
Mean Diastolic Blood Pressure
Baseline
|
85.1 mm Hg
Interval 82.9 to 87.3
|
84.4 mm Hg
Interval 82.3 to 86.6
|
|
Mean Diastolic Blood Pressure
6 Months
|
81.7 mm Hg
Interval 79.5 to 84.0
|
75.0 mm Hg
Interval 72.9 to 77.2
|
|
Mean Diastolic Blood Pressure
12 Months
|
80.8 mm Hg
Interval 78.5 to 83.2
|
75.1 mm Hg
Interval 72.8 to 77.4
|
|
Mean Diastolic Blood Pressure
18 Months
|
78.7 mm Hg
Interval 76.6 to 80.9
|
75.1 mm Hg
Interval 73.0 to 77.2
|
|
Mean Diastolic Blood Pressure
54 Months
|
79.1 mm Hg
Interval 76.8 to 81.4
|
77.8 mm Hg
Interval 75.5 to 80.1
|
Adverse Events
Usual Care
Serious events: 37 serious events
Other events: 8 other events
Deaths: 0 deaths
Telemonitoring Intervention
Serious events: 30 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=222 participants at risk
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
Telemonitoring Intervention
n=228 participants at risk
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
|---|---|---|
|
Surgical and medical procedures
Knee, hip, or shoulder arthroplasty
|
0.90%
2/222 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
1.8%
4/228 • Number of events 4 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 3 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Spinal decompression/fusion
|
2.7%
6/222 • Number of events 6 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
1.4%
3/222 • Number of events 3 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Chronic Obstructive Pulmonary Disease (COPD)
|
0.45%
1/222 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.88%
2/228 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
4/222 • Number of events 4 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.88%
2/228 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Infections and infestations
Appendicitis
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Musculoskeletal and connective tissue disorders
Acute back pain
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Nervous system disorders
Hashimoto's encephalopathy
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Fracture repair
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.88%
2/228 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Infections and infestations
Sepsis
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Hernia repair
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Thyroidectomy
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Psychiatric disorders
Pyschiatric hospitalization
|
0.90%
2/222 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Injury, poisoning and procedural complications
Overdose, toxicity, or withdrawal
|
1.8%
4/222 • Number of events 4 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Reproductive system and breast disorders
Prostate resection
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.88%
2/228 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Hysterectomy
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Cholecystectomy
|
0.90%
2/222 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Infections and infestations
Peri-operative wound infection
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
General disorders
Dehydration
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Hemorrhoid surgery
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.90%
2/222 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Surgical and medical procedures
Bladder suspension
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Hepatobiliary disorders
Ascites
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Hepatobiliary disorders
Acute abdominal pain
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
General disorders
Chest pain, non-cardiac, non-specific
|
1.8%
4/222 • Number of events 4 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
1.3%
3/228 • Number of events 4 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Cardiac disorders
Chest pain, atypical
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
1.8%
4/228 • Number of events 4 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Cardiac disorders
Hypertensive crisis
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Endocrine disorders
Hyperglycemia
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Cerebrovascular accident (stroke)
|
2.3%
5/222 • Number of events 5 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.88%
2/228 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Hypotension with syncope
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
1.3%
3/228 • Number of events 3 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Cardiac disorders
Stable angina
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Transient Ischemic Attack
|
1.4%
3/222 • Number of events 3 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Peripheral artery disease
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Coronary artery disease
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Cardiac disorders
Myocardial Infarction
|
3.6%
8/222 • Number of events 8 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
Other adverse events
| Measure |
Usual Care
n=222 participants at risk
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
Telemonitoring Intervention
n=228 participants at risk
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
|---|---|---|
|
Renal and urinary disorders
Uretral stent change
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 3 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Cardiac disorders
Hypotension, dizziness, near syncope
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
1.3%
3/228 • Number of events 3 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/222 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.44%
1/228 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Hypertensive crisis
|
0.90%
2/222 • Number of events 2 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Hypertension
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Injury, poisoning and procedural complications
Allergic reaction
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
|
Vascular disorders
Allergic vasculitis
|
0.45%
1/222 • Number of events 1 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
0.00%
0/228 • Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
|
Additional Information
Dr. Karen Margolis, MD MPH
HealthPartners Institute for Education and Research
Phone: 952-967-7301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place