Trial Outcomes & Findings for Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease) (NCT NCT01052428)
NCT ID: NCT01052428
Last Updated: 2012-11-22
Results Overview
Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
38 participants
Primary outcome timeframe
5 visits per Participant over 2 years (about every 6 months)
Results posted on
2012-11-22
Participant Flow
Participant milestones
| Measure |
Placebo
|
Toprol-XL
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
|
Toprol-XL
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
|
Toprol-XL
n=19 Participants
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
52.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 0 (n=19,19)
|
91.66 ml/m^2
Standard Deviation 16.48
|
95.74 ml/m^2
Standard Deviation 19.89
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 3 (n=1,0)
|
90.93 ml/m^2
Standard Deviation NA
n=1
|
NA ml/m^2
Standard Deviation NA
no observation
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 6 (n=17,19)
|
90.84 ml/m^2
Standard Deviation 16.39
|
95.24 ml/m^2
Standard Deviation 18.52
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 9 (n=1,0)
|
70.56 ml/m^2
Standard Deviation NA
n=1
|
NA ml/m^2
Standard Deviation NA
no observation
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 12 (n=14,15)
|
88.99 ml/m^2
Standard Deviation 16.63
|
95.71 ml/m^2
Standard Deviation 20.59
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 15 (n=3,2)
|
82.73 ml/m^2
Standard Deviation 14.18
|
98.16 ml/m^2
Standard Deviation 2.89
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 18 (n=14,18)
|
90.16 ml/m^2
Standard Deviation 21.49
|
97.6 ml/m^2
Standard Deviation 19.82
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 21 (n=5,0)
|
85.75 ml/m^2
Standard Deviation 15.24
|
NA ml/m^2
Standard Deviation NA
no observation
|
|
Left Ventricular End Diastolic Volume Indexed to Body Surface Area
Month 24 (n=16,18)
|
87.31 ml/m^2
Standard Deviation 20.91
|
95.16 ml/m^2
Standard Deviation 23.94
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 0 (n=19,19)
|
0.61 g/ml
Standard Deviation 0.13
|
0.61 g/ml
Standard Deviation 0.12
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 3 (n=1,0)
|
0.53 g/ml
Standard Deviation NA
n=1
|
NA g/ml
Standard Deviation NA
no observation
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 6 (n=17,19)
|
0.62 g/ml
Standard Deviation 0.11
|
0.6 g/ml
Standard Deviation 0.12
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 9 (n=1,1)
|
0.67 g/ml
Standard Deviation NA
n=1
|
0.53 g/ml
Standard Deviation NA
n=1
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 12 (n=14,15)
|
0.65 g/ml
Standard Deviation 0.12
|
0.60 g/ml
Standard Deviation 0.1
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 15 (n=3,2)
|
0.65 g/ml
Standard Deviation 0.18
|
0.55 g/ml
Standard Deviation 0.05
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 18 (n=14,18)
|
0.65 g/ml
Standard Deviation 0.11
|
0.59 g/ml
Standard Deviation 0.09
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 21 (n=5,0)
|
0.61 g/ml
Standard Deviation 0.13
|
NA g/ml
Standard Deviation NA
no observation
|
|
Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume
Month 24 (n=16,18)
|
0.64 g/ml
Standard Deviation 0.12
|
0.62 g/ml
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 0 (n=19,19)
|
4.76 unitless
Standard Deviation 0.92
|
4.69 unitless
Standard Deviation 0.92
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 3 (n=1,0)
|
5.02 unitless
Standard Deviation NA
n=1
|
NA unitless
Standard Deviation NA
no observation
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 6 (n=17,19)
|
4.51 unitless
Standard Deviation 0.62
|
4.85 unitless
Standard Deviation 0.92
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 9 (n=1,1)
|
4.15 unitless
Standard Deviation NA
n=1
|
5.74 unitless
Standard Deviation NA
n=1
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 12 (n=14,15)
|
4.46 unitless
Standard Deviation 0.64
|
4.79 unitless
Standard Deviation 0.95
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 15 (n=3,2)
|
4.61 unitless
Standard Deviation 1.69
|
5.02 unitless
Standard Deviation 0.48
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 18 (n=14,18)
|
4.43 unitless
Standard Deviation 0.69
|
4.77 unitless
Standard Deviation 0.83
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 21 (n=5,0)
|
4.72 unitless
Standard Deviation 0.91
|
NA unitless
Standard Deviation NA
no observation
|
|
Left Ventricular End-Diastolic Radius to Wall Thickness
Month 24 (n=16,18)
|
4.52 unitless
Standard Deviation 0.78
|
4.59 unitless
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 0 (n=19,19)
|
34.01 ml/m^2
Standard Deviation 6.86
|
35.98 ml/m^2
Standard Deviation 8.12
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 3 (n=1,0)
|
32.83 ml/m^2
Standard Deviation NA
n=1
|
NA ml/m^2
Standard Deviation NA
no observation
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 6 (n=17,19)
|
32.53 ml/m^2
Standard Deviation 6.15
|
36.53 ml/m^2
Standard Deviation 6.76
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 9 (n=1,0)
|
40.99 ml/m^2
Standard Deviation NA
n=1
|
NA ml/m^2
Standard Deviation NA
no observation
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 12 (n=14,15)
|
33.70 ml/m^2
Standard Deviation 7.62
|
35.89 ml/m^2
Standard Deviation 10.52
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 15 (n=3,2)
|
47.25 ml/m^2
Standard Deviation 21.32
|
30.97 ml/m^2
Standard Deviation 2.9
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 18 (n=14,18)
|
34.99 ml/m^2
Standard Deviation 10.08
|
36.72 ml/m^2
Standard Deviation 8.04
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 21 (n=5,0)
|
39.97 ml/m^2
Standard Deviation 13.22
|
NA ml/m^2
Standard Deviation NA
no observation
|
|
Left Ventricular End Systolic Volume Indexed to Body Surface Area
Month 24 (n=16,18)
|
34.47 ml/m^2
Standard Deviation 8.72
|
35.13 ml/m^2
Standard Deviation 10.47
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Left Ventricular Ejection Fraction
Month 21 (n=5,0)
|
53.79 percent
Standard Deviation 11.20
|
NA percent
Standard Deviation NA
no observation
|
|
Left Ventricular Ejection Fraction
Month 0 (n=19,19)
|
62.62 percent
Standard Deviation 5.25
|
62.09 percent
Standard Deviation 6.45
|
|
Left Ventricular Ejection Fraction
Month 3 (n=1,0)
|
63.90 percent
Standard Deviation NA
n=1
|
NA percent
Standard Deviation NA
no observation
|
|
Left Ventricular Ejection Fraction
Month 6 (n=17,19)
|
63.80 percent
Standard Deviation 6.15
|
61.29 percent
Standard Deviation 4.66
|
|
Left Ventricular Ejection Fraction
Month 9 (n=1,1)
|
41.90 percent
Standard Deviation NA
n=1
|
54.81 percent
Standard Deviation NA
n=1
|
|
Left Ventricular Ejection Fraction
Month 12 (n=14,15)
|
61.70 percent
Standard Deviation 6.87
|
62.77 percent
Standard Deviation 6.14
|
|
Left Ventricular Ejection Fraction
Month 15 (n=3,2)
|
44.70 percent
Standard Deviation 16.03
|
68.47 percent
Standard Deviation 2.02
|
|
Left Ventricular Ejection Fraction
Month 18 (n=14,18)
|
60.95 percent
Standard Deviation 8.23
|
62.05 percent
Standard Deviation 5.68
|
|
Left Ventricular Ejection Fraction
Month 24 (n=16,18)
|
59.95 percent
Standard Deviation 8.27
|
63.02 percent
Standard Deviation 6.05
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Systolic Longitudinal Strain
Month 12 (n=14,15)
|
87.85 percent/%Systolic interval
Standard Deviation 26.07
|
80.04 percent/%Systolic interval
Standard Deviation 20.58
|
|
Systolic Longitudinal Strain
Month 15 (n=3,2)
|
52.95 percent/%Systolic interval
Standard Deviation 20.87
|
88.34 percent/%Systolic interval
Standard Deviation 6.70
|
|
Systolic Longitudinal Strain
Month 18 (n=14,18)
|
88.11 percent/%Systolic interval
Standard Deviation 34.96
|
79.29 percent/%Systolic interval
Standard Deviation 22.14
|
|
Systolic Longitudinal Strain
Month 21 (n=5,0)
|
67.53 percent/%Systolic interval
Standard Deviation 26.81
|
NA percent/%Systolic interval
Standard Deviation NA
no observation
|
|
Systolic Longitudinal Strain
Month 24 (n=16,18)
|
79.94 percent/%Systolic interval
Standard Deviation 24.24
|
85.18 percent/%Systolic interval
Standard Deviation 32.2
|
|
Systolic Longitudinal Strain
Month 0 (n=19,19)
|
87.94 percent/%Systolic interval
Standard Deviation 27.44
|
82.55 percent/%Systolic interval
Standard Deviation 29.31
|
|
Systolic Longitudinal Strain
Month 3 (n=1,0)
|
115.07 percent/%Systolic interval
Standard Deviation NA
n=1
|
NA percent/%Systolic interval
Standard Deviation NA
no observation
|
|
Systolic Longitudinal Strain
Month 6 (n=17,19)
|
45.90 percent/%Systolic interval
Standard Deviation 34.56
|
78.68 percent/%Systolic interval
Standard Deviation 22.97
|
|
Systolic Longitudinal Strain
Month 9 (n=1,0)
|
37.2 percent/%Systolic interval
Standard Deviation NA
n=1
|
NA percent/%Systolic interval
Standard Deviation NA
no observation
|
PRIMARY outcome
Timeframe: 5 visits per Participant over 2 years (about every 6 months)Population: intent to treat
Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle.
Outcome measures
| Measure |
Placebo
n=19 Participants
Pill that looks like Toprol XL but does not have the active ingredients
|
Toprol XL
n=19 Participants
Generic name metoprolol succinate
|
|---|---|---|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 0 (n=19,19)
|
2.27 EDV/sec
Standard Deviation 0.61
|
2.12 EDV/sec
Standard Deviation 0.57
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 3 (n=1,0)
|
2.58 EDV/sec
Standard Deviation NA
n=1
|
NA EDV/sec
Standard Deviation NA
no observation
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 6 (n=17,19)
|
2.38 EDV/sec
Standard Deviation 0.53
|
2.08 EDV/sec
Standard Deviation 0.55
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 9 (n=1,0)
|
1.56 EDV/sec
Standard Deviation NA
n=1
|
NA EDV/sec
Standard Deviation NA
no observation
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 12 (n=14,15)
|
2.26 EDV/sec
Standard Deviation 0.52
|
2.24 EDV/sec
Standard Deviation 0.46
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 15 (n=3,2)
|
1.83 EDV/sec
Standard Deviation 1.56
|
2.28 EDV/sec
Standard Deviation 0.47
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 18 (n=14,18)
|
1.95 EDV/sec
Standard Deviation 0.63
|
2.26 EDV/sec
Standard Deviation 0.56
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 21 (n=5,0)
|
1.73 EDV/sec
Standard Deviation 0.99
|
NA EDV/sec
Standard Deviation NA
no observation
|
|
Peak Early Filling Rate: Rate of Change Over Time
Month 24 (n=16,18)
|
2.17 EDV/sec
Standard Deviation 0.60
|
2.25 EDV/sec
Standard Deviation 0.63
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 6 other events
Deaths: 0 deaths
Toprol-XL
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=19 participants at risk
|
Toprol-XL
n=19 participants at risk
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Continued right calf pain
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Surgical and medical procedures
Death
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
|
Ear and labyrinth disorders
Hearing loss and tinnitus
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Cardiac disorders
Mitral Valve Replacement
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Cardiac disorders
Mitral valve repair
|
26.3%
5/19 • Number of events 5 • 2 years
visit is every 6 months
|
10.5%
2/19 • Number of events 2 • 2 years
visit is every 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion and thoracentesis
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Renal and urinary disorders
Prostrate cancer
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
Other adverse events
| Measure |
Placebo
n=19 participants at risk
|
Toprol-XL
n=19 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Psychiatric disorders
anxiety
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Gastrointestinal disorders
colon polyp removed
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
|
Nervous system disorders
headaches
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Endocrine disorders
hyperlipidemia
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Cardiac disorders
hypertension
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
|
Musculoskeletal and connective tissue disorders
left foot pain
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
|
Musculoskeletal and connective tissue disorders
left upper arm broken
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
|
Endocrine disorders
nodule rt of thyroid
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
0.00%
0/19 • 2 years
visit is every 6 months
|
|
Infections and infestations
sinus infection
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
|
Musculoskeletal and connective tissue disorders
tendonitis rt shoulder
|
0.00%
0/19 • 2 years
visit is every 6 months
|
5.3%
1/19 • Number of events 1 • 2 years
visit is every 6 months
|
Additional Information
Louis J. Dell'Italia, M.D.
University of Alabama at Birmingham
Phone: 205-934-0850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place