Trial Outcomes & Findings for Pulmonary Hypertension and Anastrozole Trial (NCT NCT03229499)
NCT ID: NCT03229499
Last Updated: 2024-05-01
Results Overview
Change in the distance walked in six minutes adjusted for baseline value and sex
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
6 months
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
Anastrozole
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
|
Overall Study
COMPLETED
|
43
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pulmonary Hypertension and Anastrozole Trial
Baseline characteristics by cohort
| Measure |
Anastrozole
n=43 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=41 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
77 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Six-minute walk distance
|
442.8 meters
STANDARD_DEVIATION 119.5 • n=5 Participants
|
416.3 meters
STANDARD_DEVIATION 115.3 • n=7 Participants
|
429.8 meters
STANDARD_DEVIATION 117.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data. Includes non-missing six-minute walk distance at 6 months
Change in the distance walked in six minutes adjusted for baseline value and sex
Outcome measures
| Measure |
Anastrozole
n=41 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=38 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in Six-minute Walk Distance
|
1.53 meters
Interval -15.92 to 18.99
|
9.45 meters
Interval -8.64 to 27.54
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data.
Change in tricuspid annular systolic plane excursion (TAPSE) adjusted for baseline value and sex. TAPSE is a measure of right ventricular function that is measured via cardiac echography
Outcome measures
| Measure |
Anastrozole
n=33 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=34 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in Right Ventricular Function: Tricuspid Annular Systolic Plane Excursion (TAPSE)
|
-0.97 millimeters
Interval -2.39 to 0.45
|
-0.08 millimeters
Interval -1.46 to 1.3
|
SECONDARY outcome
Timeframe: 6monthsPopulation: Please note that some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data
Change in log10 NT-proBNP adjusted for baseline value and sex
Outcome measures
| Measure |
Anastrozole
n=40 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=39 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in Plasma NT-proBNP
|
0.06 log10(pg/ml)
Interval -0.04 to 0.15
|
0.04 log10(pg/ml)
Interval -0.06 to 0.14
|
SECONDARY outcome
Timeframe: 6monthsPopulation: Please note that some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data.
Change in the Medical Outcomes Study Questionnaire Short Form-36 (SF36) physical component summary (PCS) score adjusted for baseline value and sex. SF36 PCS score is a subjective measure of physical health status, with scores ranging from 0 to 100. Higher scores represent better health status.
Outcome measures
| Measure |
Anastrozole
n=42 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=40 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in the Medical Outcomes Study Questionnaire Short Form-36 (SF36) Physical Component Summary (PCS) Score Adjusted for Baseline Value and Sex.
|
1.38 units on a scale
Interval -0.34 to 3.1
|
0.02 units on a scale
Interval -1.76 to 1.79
|
SECONDARY outcome
Timeframe: 6monthsPopulation: Please note that some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data.
Change in the emPHasis-10 score adjusted for baseline value and sex. EmPHasis-10 is a pulmonary hypertension-specific measure of quality of life which is scored from 0-50, with higher scores indicating worse quality of life.
Outcome measures
| Measure |
Anastrozole
n=43 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=40 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in the emPHasis-10 Score Adjusted for Baseline Value and Sex
|
-0.27 units on a scale
Interval -2.34 to 1.81
|
-0.51 units on a scale
Interval -2.68 to 1.66
|
SECONDARY outcome
Timeframe: 6monthsPopulation: Please note that some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data.
Actigraphy-measured vector magnitude count is an estimate of physical activity intensity. The total vector magnitude counts per day was measured over 7 days using an actigraphy device, and the median value over the 7 days was obtained. This outcome measure is the change in the 7-day median value from baseline to follow-up, adjusted for the baseline value, sex, and actigraphy device wear time.
Outcome measures
| Measure |
Anastrozole
n=42 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=38 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in Actigraphy-measured Physical Activity: Change in 7-day Median Daily Vector Magnitude Count
|
-0.43 counts per day(x10^5)
Interval -0.69 to -0.18
|
-0.28 counts per day(x10^5)
Interval -0.55 to 0.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Please note that some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data
Number of participants with a clinical worsening event. Clinical worsening was defined as the addition of new PAH therapies or dose increases in previously stable PAH therapy for increased symptoms, hospitalization for PAH progression and/or right-sided heart failure, lung transplantation, atrial septostomy, or all-cause death.' Unit of Measure is retained as 'Participants.
Outcome measures
| Measure |
Anastrozole
n=43 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=41 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Number of Participants With a Clinical Worsening Event Between Anastrozole and Placebo Groups
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Please note that some participants are missing data at follow-up and the Analysis Population includes only participants with non-missing data
Change in lumbar spine bone mineral density adjusted for baseline value and sex between anastrozole and placebo groups
Outcome measures
| Measure |
Anastrozole
n=43 Participants
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=34 Participants
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Change in Bone Mineral Density: Lumbar Spine Between Anastrozole and Placebo Groups
|
0 g/cm^2
Interval -0.02 to 0.01
|
0 g/cm^2
Interval -0.02 to 0.02
|
Adverse Events
Anastrozole
Serious events: 16 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 38 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Anastrozole
n=43 participants at risk
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=41 participants at risk
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Surgical and medical procedures
Catheter placement
|
4.7%
2/43 • Number of events 2 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
2/43 • Number of events 2 • 12 months
|
0.00%
0/41 • 12 months
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.7%
2/43 • Number of events 2 • 12 months
|
0.00%
0/41 • 12 months
|
|
Immune system disorders
Anaphylaxis
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma hepatocellular
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest pain - cardiac
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Skin and subcutaneous tissue disorders
Chronic leg ulcer
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Infections and infestations
Coronavirus infection
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
General disorders
Disease progression
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Gastrointestinal disorders
Esophagitis
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Metabolism and nutrition disorders
Fluid retention in tissues
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Gastrointestinal disorders
Mallory Weiss tear
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
General disorders
Pelvic mass
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Nervous system disorders
Seizure
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.3%
1/43 • Number of events 1 • 12 months
|
0.00%
0/41 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/43 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Anastrozole
n=43 participants at risk
1mg (1 tablet)taken by mouth once a day for one year
Anastrozole: Anastrozole is an aromatase inhibitor indicated for:
* adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
* first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
* treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
|
Placebo
n=41 participants at risk
1 tablet taken by mouth once a day for one year
Placebo Oral Tablet: matching placebo tablet
|
|---|---|---|
|
Infections and infestations
Upper respiratory infection
|
20.9%
9/43 • Number of events 13 • 12 months
|
14.6%
6/41 • Number of events 7 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
6/43 • Number of events 7 • 12 months
|
9.8%
4/41 • Number of events 5 • 12 months
|
|
General disorders
Edema limbs
|
11.6%
5/43 • Number of events 6 • 12 months
|
12.2%
5/41 • Number of events 5 • 12 months
|
|
Vascular disorders
Hot flashes
|
14.0%
6/43 • Number of events 6 • 12 months
|
9.8%
4/41 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.6%
5/43 • Number of events 5 • 12 months
|
9.8%
4/41 • Number of events 6 • 12 months
|
|
Nervous system disorders
Headache
|
11.6%
5/43 • Number of events 8 • 12 months
|
9.8%
4/41 • Number of events 4 • 12 months
|
|
Psychiatric disorders
Depression
|
7.0%
3/43 • Number of events 3 • 12 months
|
12.2%
5/41 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • Number of events 3 • 12 months
|
12.2%
5/41 • Number of events 6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
3/43 • Number of events 3 • 12 months
|
12.2%
5/41 • Number of events 5 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • Number of events 4 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.6%
5/43 • Number of events 6 • 12 months
|
4.9%
2/41 • Number of events 3 • 12 months
|
|
General disorders
Fatigue
|
9.3%
4/43 • Number of events 6 • 12 months
|
7.3%
3/41 • Number of events 4 • 12 months
|
|
Vascular disorders
Hypotension
|
4.7%
2/43 • Number of events 2 • 12 months
|
9.8%
4/41 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.0%
3/43 • Number of events 3 • 12 months
|
4.9%
2/41 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
4/43 • Number of events 5 • 12 months
|
2.4%
1/41 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
1/43 • Number of events 1 • 12 months
|
9.8%
4/41 • Number of events 4 • 12 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
4.7%
2/43 • Number of events 3 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 2 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
2.3%
1/43 • Number of events 1 • 12 months
|
7.3%
3/41 • Number of events 4 • 12 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/43 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/43 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/43 • 12 months
|
7.3%
3/41 • Number of events 3 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
7.0%
3/43 • Number of events 3 • 12 months
|
0.00%
0/41 • 12 months
|
Additional Information
Dr. Steven M Kawut, MD, MS
Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine
Phone: 646-352-1654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place