The LIFE Study - Lifestyle Interventions and Independence for Elders
Study Details
Study Description
Brief Summary
Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years.
The primary aim was to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
As life expectancy in the United States continues to rise, the maintenance of physical independence among older Americans has emerged as a major clinical and public health priority. Efficient and reliable locomotion, or the ability to move without assistance, is a fundamental feature of human functioning. Older people who lose mobility are less likely to remain in the community, have higher rates of morbidity, mortality, and hospitalizations and experience a poorer quality of life. Several studies have shown that regular physical activity improves physical performance, but definitive evidence showing that mobility disability can be prevented was lacking. A Phase 3 randomized controlled trial was needed to fill this evidence gap.
The LIFE Study was a Phase 3, multicenter randomized controlled trial (RCT) designed to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older persons who are followed for an average of 2.7 years. The primary outcome was major mobility disability, defined as inability to walk 400 m. Secondary outcomes include cognitive function based on the Digit Symbol Substitution Test (DSST) and the Hopkins Verbal Learning Test (HVLT); serious fall injuries; persistent mobility disability; the combined outcome of major mobility disability or death; disability in activities of daily living; and cost-effectiveness. Tertiary outcomes include the combined outcome of mild cognitive impairment or dementia, a composite measure of the cognitive assessment battery, physical performance within pre-specified subgroups defined on the basis of race, gender and baseline physical performance, sleep-wake disturbances, dyspnea, ventilatory capacity, cardiopulmonary events, and cardiovascular events.
The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. This trial provides definitive evidence regarding whether physical activity is effective and practical for preventing major mobility disability. These results will have crucial implications for public health prevention in a rapidly aging society, and will fill an important gap in knowledge for practicing evidence-based geriatric medicine. The study will also yield valuable information concerning the efficacy and effectiveness of physical activity across a broad spectrum of important health outcomes. The study will impact both clinical practice and public health policy, and will, therefore, benefit individuals and society.
The Coordinating Center was at the University of Florida and the Data Management Analysis and Quality Control Center (DMAQC) was at Wake Forest University School of Medicine. The 8 field sites participating in the LIFE Study are University of Florida, Gainesville, Florida; Northwestern University, Chicago, Illinois; Pennington Biomedical Research Center, Baton Rouge, Louisiana; University of Pittsburgh, Pittsburgh, Pennsylvania; Stanford University, Palo Alto, California; Tufts University, Boston, Massachusetts; Wake Forest University, Winston-Salem, North Carolina; and Yale University, New Haven, Connecticut.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Physical Activity The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. |
Behavioral: Physical Activity
The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
|
| Active Comparator: Successful Aging The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. |
Behavioral: Successful Aging
The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Major Mobility Disability, Defined as Incapacity to Walk 400 Meters [Median 2.7 years/Average 2.6 years]
The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.
Secondary Outcome Measures
- Persistent Mobility Disability (Assessed Every 6 Months) [Median 2.7 years/Average 2.6 years]
The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.
Eligibility Criteria
Criteria
Inclusion Criteria:
- age 70 to 89 years; (2) summary score <10 on the short physical performance battery (SPPB) (45% are <8);90 (3) sedentary lifestyle; (4) ability to complete the 400 m walk test without an assistive device; and (5) willingness to be randomized to either intervention group.
Exclusion Criteria:
Exclusion Criteria for Factors that May Limit Adherence to Interventions or Affect Conduct of the Trial • Unable or unwilling to give informed consent or accept randomization in either study group • Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
-
Current consumption of more than 14 alcoholic drinks per week
-
Plans to relocate to out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year
-
Self-reported inability to walk across a small room
-
The use of a walker to complete the 400 m walk and/or unable to complete the 400 m walk without sitting down or the help of another person
-
Another member of the household is a participant in the Life Study
-
Residence too far from the intervention site
-
Residence in a nursing home
-
Difficulty in communication with study personnel due to speech or hearing problems
-
Modified Mini-Mental State Exam (3MSE) score below the cutoff for education:
African American, 9+ yrs 76, <9 yrs 70; English Speaking Non-African American, 9+ yrs 80, <9 yrs 76; Spanish Speaking, 9+ yrs 80, <9 yrs 70
-
Participation in LIFE-Pilot study
-
Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Exclusion Criteria for Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions
• Severe arthritis (either osteoarthritis or rheumatoid arthritis)
• Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
• Lung disease requiring either regular use of corticosteroid pills or injections or the use of supplemental oxygen
• Development of chest pain or severe shortness of breath on a 400 m self-paced walk test
• Cardiovascular disease (including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history or cardiac arrest, use of a cardiac defibrillator or uncontrolled angina)
• Parkinson's disease or other serious neurological disorder
• Renal disease requiring dialysis
• Other illness of such severity that life expectancy is considered to be less than 12 months
• Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site
Temporary Exclusion Criteria
• Uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
• Uncontrolled diabetes with recent weight loss, diabetic coma or frequent insulin reactions.
-
Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months.
-
Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG.
-
Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months.
-
Undergoing physical therapy or cardiopulmonary rehabilitation
-
Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94304 |
| 2 | Yale University | New Haven | Connecticut | United States | 06510 |
| 3 | University of Florida | Gainesville | Florida | United States | 32608 |
| 4 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 5 | Pennington Biodmedical Research | Baton Rouge | Louisiana | United States | 70808 |
| 6 | Tufts University | Boston | Massachusetts | United States | 02111 |
| 7 | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
| 8 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Florida
- National Institute on Aging (NIA)
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Marco Pahor, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
- Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.
- LIFE Study Investigators, Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. Erratum in: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337.
- IRB201701066-N
- 3U01AG022376-05A2S1
- U01AG022376
Study Results
Participant Flow
| Recruitment Details | 1,635 participants were randomized over 21-months, with the target of 1,600 reached late Nov 2011. The 1st randomization occurred 3/12/10, and the final randomization on 12/27/11. Participants in the recruitment pipeline completed screening and testing visits and were randomized; hence, the total randomized exceeded the target. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Physical Activity | Successful Aging (Health Education) |
|---|---|---|
| Arm/Group Description | The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. | The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. |
| Period Title: Overall Study | ||
| STARTED | 818 | 817 |
| COMPLETED | 794 | 803 |
| NOT COMPLETED | 24 | 14 |
Baseline Characteristics
| Arm/Group Title | Physical Activity | Successful Aging | Total |
|---|---|---|---|
| Arm/Group Description | The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. | The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. | Total of all reporting groups |
| Overall Participants | 818 | 817 | 1635 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
78.7
(5.2)
|
79.1
(5.2)
|
78.9
(5.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
547
66.9%
|
551
67.4%
|
1098
67.2%
|
| Male |
271
33.1%
|
266
32.6%
|
537
32.8%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Hispanic |
31
3.8%
|
30
3.7%
|
61
3.7%
|
| White |
604
73.8%
|
635
77.7%
|
1239
75.8%
|
| African American |
163
19.9%
|
125
15.3%
|
288
17.6%
|
| Asian |
7
0.9%
|
8
1%
|
15
0.9%
|
| Other/Mixed |
10
1.2%
|
17
2.1%
|
27
1.7%
|
| Refused/Missing |
3
0.4%
|
2
0.2%
|
5
0.3%
|
| Education (participants) [Number] | |||
| No formal eduction |
7
0.9%
|
6
0.7%
|
13
0.8%
|
| Elementary School (k-8) |
15
1.8%
|
17
2.1%
|
32
2%
|
| High school/equivalent (9-12) |
248
30.3%
|
236
28.9%
|
484
29.6%
|
| College (13-17) |
321
39.2%
|
320
39.2%
|
641
39.2%
|
| Post Graduate |
194
23.7%
|
208
25.5%
|
402
24.6%
|
| Other |
32
3.9%
|
26
3.2%
|
58
3.5%
|
| Unknown |
1
0.1%
|
4
0.5%
|
5
0.3%
|
| Total SPPB Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
7.4
(1.6)
|
7.3
(1.6)
|
7.4
(1.6)
|
| 3MSE Score, 0-100 scale, mean (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
91.5
(5.6)
|
91.6
(5.5)
|
91.5
(5.5)
|
| CHAMPS 18 Total Score (hours/week) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [hours/week] |
15.9
(32.1)
|
18.2
(33.8)
|
17.0
(33.0)
|
| Total Cholesterol (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
179.3
(39.6)
|
178.5
(39.9)
|
178.9
(39.8)
|
| Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
127.9
(18.1)
|
127.0
(17.8)
|
127.4
(18.0)
|
| Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmHg] |
68.7
(10.3)
|
67.7
(10.1)
|
68.2
(10.2)
|
| Weight (kg) (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
81.9
(18.4)
|
82.0
(19.3)
|
81.9
(18.8)
|
| Body Mass Index, mean (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
30.1
(5.9)
|
30.3
(6.2)
|
30.2
(6.1)
|
| High blood pressure/hypertension (participants) [Number] | |||
| Number [participants] |
573
70%
|
578
70.7%
|
1151
70.4%
|
| Heart Attack/Coronary/MI (participants) [Number] | |||
| Number [participants] |
60
7.3%
|
69
8.4%
|
129
7.9%
|
| Heart failure/congestive heart failure (participants) [Number] | |||
| Number [participants] |
26
3.2%
|
45
5.5%
|
71
4.3%
|
| Pacemaker (participants) [Number] | |||
| Number [participants] |
33
4%
|
33
4%
|
66
4%
|
| Stroke (participants) [Number] | |||
| Number [participants] |
57
7%
|
52
6.4%
|
109
6.7%
|
| Cancer (participants) [Number] | |||
| Number [participants] |
178
21.8%
|
192
23.5%
|
370
22.6%
|
| Diabetes/High Blood Sugar (participants) [Number] | |||
| Number [participants] |
198
24.2%
|
216
26.4%
|
414
25.3%
|
| Chronic lung disease (participants) [Number] | |||
| Number [participants] |
130
15.9%
|
123
15.1%
|
253
15.5%
|
Outcome Measures
| Title | Major Mobility Disability, Defined as Incapacity to Walk 400 Meters |
|---|---|
| Description | The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes. |
| Time Frame | Median 2.7 years/Average 2.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Physical Activity | Successful Aging |
|---|---|---|
| Arm/Group Description | The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. | The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. |
| Measure Participants | 818 | 817 |
| Number [participants] |
246
30.1%
|
290
35.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Physical Activity, Successful Aging |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.82 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 0.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Persistent Mobility Disability (Assessed Every 6 Months) |
|---|---|
| Description | The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death. |
| Time Frame | Median 2.7 years/Average 2.6 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Physical Activity | Successful Aging |
|---|---|---|
| Arm/Group Description | The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. | The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. |
| Measure Participants | 818 | 817 |
| Number [participants] |
120
14.7%
|
162
19.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Physical Activity, Successful Aging |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | Regression, Cox | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.72 | |
| Confidence Interval |
(2-Sided) 95% 0.57 to 0.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried every 6 months but could report adverse events in-between visits. Participants were followed for an average of 2.6 years. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | To minimize reporting bias, adverse events originating from the blinded assessments are presented. Blinded assessments were completed every 6 months. Non-serious AEs were collected without regard to the specific AE term. | |||
| Arm/Group Title | Physical Activity | Successful Aging | ||
| Arm/Group Description | The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling. | The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises. | ||
All Cause Mortality |
||||
| Physical Activity | Successful Aging | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Physical Activity | Successful Aging | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 404/818 (49.4%) | 373/817 (45.7%) | ||
| Blood and lymphatic system disorders | ||||
| ANEMIA | 10/818 (1.2%) | 15 | 6/817 (0.7%) | 6 |
| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | 2/818 (0.2%) | 2 | 2/817 (0.2%) | 2 |
| FEBRILE NEUTROPENIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 4 |
| Cardiac disorders | ||||
| ACUTE CORONARY SYNDROME | 6/818 (0.7%) | 6 | 6/817 (0.7%) | 6 |
| AORTIC VALVE DISEASE | 3/818 (0.4%) | 3 | 2/817 (0.2%) | 2 |
| ASYSTOLE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| ATRIAL FIBRILLATION | 23/818 (2.8%) | 28 | 19/817 (2.3%) | 23 |
| ATRIAL FLUTTER | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| ATRIOVENTRICULAR BLOCK COMPLETE | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| CARDIAC ARREST | 6/818 (0.7%) | 6 | 7/817 (0.9%) | 7 |
| CARDIAC DISORDERS - OTHER, SPECIFY | 11/818 (1.3%) | 11 | 8/817 (1%) | 8 |
| CHEST PAIN - CARDIAC | 18/818 (2.2%) | 24 | 12/817 (1.5%) | 14 |
| CONDUCTION DISORDER | 1/818 (0.1%) | 1 | 2/817 (0.2%) | 2 |
| HEART FAILURE | 20/818 (2.4%) | 24 | 16/817 (2%) | 23 |
| MYOCARDIAL INFARCTION | 14/818 (1.7%) | 14 | 12/817 (1.5%) | 13 |
| PALPITATIONS | 1/818 (0.1%) | 2 | 1/817 (0.1%) | 1 |
| PAROXYSMAL ATRIAL TACHYCARDIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| PERICARDITIS | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| RESTRICTIVE CARDIOMYOPATHY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| SINUS BRADYCARDIA | 3/818 (0.4%) | 3 | 7/817 (0.9%) | 7 |
| SUPRAVENTRICULAR TACHYCARDIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| VENTRICULAR ARRHYTHMIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| VENTRICULAR TACHYCARDIA | 2/818 (0.2%) | 3 | 0/817 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| VERTIGO | 5/818 (0.6%) | 5 | 6/817 (0.7%) | 6 |
| Endocrine disorders | ||||
| ADRENAL INSUFFICIENCY | 1/818 (0.1%) | 2 | 0/817 (0%) | 0 |
| ENDOCRINE DISORDERS - OTHER, SPECIFY | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| HYPERPARATHYROIDISM | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| HYPERTHYROIDISM | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| HYPOPARATHYROIDISM | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 12/818 (1.5%) | 12 | 6/817 (0.7%) | 7 |
| COLITIS | 4/818 (0.5%) | 4 | 3/817 (0.4%) | 3 |
| COLONIC FISTULA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| COLONIC HEMORRHAGE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| COLONIC OBSTRUCTION | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| COLONIC PERFORATION | 1/818 (0.1%) | 1 | 2/817 (0.2%) | 2 |
| CONSTIPATION | 1/818 (0.1%) | 2 | 2/817 (0.2%) | 2 |
| DIARRHEA | 3/818 (0.4%) | 3 | 4/817 (0.5%) | 4 |
| DYSPEPSIA | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| DYSPHAGIA | 1/818 (0.1%) | 1 | 3/817 (0.4%) | 3 |
| ENTEROCOLITIS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| ESOPHAGEAL OBSTRUCTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| ESOPHAGEAL STENOSIS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| ESOPHAGEAL ULCER | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| GASTRIC HEMORRHAGE | 4/818 (0.5%) | 4 | 0/817 (0%) | 0 |
| GASTRIC ULCER | 2/818 (0.2%) | 2 | 4/817 (0.5%) | 5 |
| GASTRITIS | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| GASTROESOPHAGEAL REFLUX DISEASE | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | 5/818 (0.6%) | 8 | 3/817 (0.4%) | 3 |
| GASTROINTESTINAL PAIN | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| HEMORRHOIDS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| ILEAL OBSTRUCTION | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| INTRA-ABDOMINAL HEMORRHAGE | 3/818 (0.4%) | 3 | 0/817 (0%) | 0 |
| JEJUNAL OBSTRUCTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| LOWER GASTROINTESTINAL HEMORRHAGE | 2/818 (0.2%) | 3 | 1/817 (0.1%) | 1 |
| NAUSEA | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| OBSTRUCTION GASTRIC | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| PANCREATIC NECROSIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| PANCREATITIS | 2/818 (0.2%) | 2 | 5/817 (0.6%) | 5 |
| RECTAL HEMORRHAGE | 3/818 (0.4%) | 3 | 2/817 (0.2%) | 3 |
| RECTAL PERFORATION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| RECTAL STENOSIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| SMALL INTESTINAL OBSTRUCTION | 8/818 (1%) | 8 | 2/817 (0.2%) | 2 |
| STOMACH PAIN | 0/818 (0%) | 0 | 2/817 (0.2%) | 2 |
| VOMITING | 4/818 (0.5%) | 6 | 3/817 (0.4%) | 3 |
| General disorders | ||||
| DEATH NOS | 4/818 (0.5%) | 4 | 3/817 (0.4%) | 3 |
| EDEMA LIMBS | 0/818 (0%) | 0 | 3/817 (0.4%) | 3 |
| EDEMA TRUNK | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| FATIGUE | 3/818 (0.4%) | 3 | 1/817 (0.1%) | 1 |
| FEVER | 1/818 (0.1%) | 5 | 1/817 (0.1%) | 2 |
| FLU LIKE SYMPTOMS | 0/818 (0%) | 0 | 3/817 (0.4%) | 3 |
| GAIT DISTURBANCE | 1/818 (0.1%) | 2 | 0/817 (0%) | 0 |
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY | 31/818 (3.8%) | 49 | 27/817 (3.3%) | 46 |
| INJECTION SITE REACTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| MALAISE | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| NON-CARDIAC CHEST PAIN | 11/818 (1.3%) | 11 | 8/817 (1%) | 9 |
| PAIN | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Hepatobiliary disorders | ||||
| CHOLECYSTITIS | 3/818 (0.4%) | 3 | 2/817 (0.2%) | 2 |
| GALLBLADDER NECROSIS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| GALLBLADDER OBSTRUCTION | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| GALLBLADDER PAIN | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| HEPATIC FAILURE | 1/818 (0.1%) | 2 | 0/817 (0%) | 0 |
| HEPATIC HEMORRHAGE | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| HEPATOBILIARY DISORDERS - OTHER, SPECIFY | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| Immune system disorders | ||||
| ALLERGIC REACTION | 5/818 (0.6%) | 7 | 1/817 (0.1%) | 1 |
| ANAPHYLAXIS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Infections and infestations | ||||
| ABDOMINAL INFECTION | 0/818 (0%) | 0 | 2/817 (0.2%) | 2 |
| ANORECTAL INFECTION | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| APPENDICITIS | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| APPENDICITIS PERFORATED | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| BILIARY TRACT INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| BLADDER INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| BONE INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| BRONCHIAL INFECTION | 8/818 (1%) | 9 | 4/817 (0.5%) | 4 |
| CATHETER RELATED INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| DEVICE RELATED INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| ENCEPHALITIS INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| ENTEROCOLITIS INFECTIOUS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| GALLBLADDER INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | 6/818 (0.7%) | 6 | 1/817 (0.1%) | 1 |
| JOINT INFECTION | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| KIDNEY INFECTION | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| LARYNGITIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| LUNG INFECTION | 15/818 (1.8%) | 17 | 15/817 (1.8%) | 16 |
| OVARIAN INFECTION | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| PHARYNGITIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| PROSTATE INFECTION | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| SALIVARY GLAND INFECTION | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| SEPSIS | 7/818 (0.9%) | 7 | 3/817 (0.4%) | 3 |
| SINUSITIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| SKIN INFECTION | 6/818 (0.7%) | 6 | 7/817 (0.9%) | 9 |
| SOFT TISSUE INFECTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| UPPER RESPIRATORY INFECTION | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| URINARY TRACT INFECTION | 11/818 (1.3%) | 11 | 13/817 (1.6%) | 14 |
| WOUND INFECTION | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| ANKLE FRACTURE | 2/818 (0.2%) | 2 | 1/817 (0.1%) | 1 |
| FALL | 28/818 (3.4%) | 29 | 31/817 (3.8%) | 35 |
| FRACTURE | 18/818 (2.2%) | 19 | 19/817 (2.3%) | 19 |
| HIP FRACTURE | 4/818 (0.5%) | 4 | 4/817 (0.5%) | 4 |
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| INTRAOPERATIVE CARDIAC INJURY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| SEROMA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| SPINAL FRACTURE | 4/818 (0.5%) | 4 | 3/817 (0.4%) | 3 |
| WOUND DEHISCENCE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| WRIST FRACTURE | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Investigations | ||||
| CREATININE INCREASED | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| INR INCREASED | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| PLATELET COUNT DECREASED | 2/818 (0.2%) | 3 | 0/817 (0%) | 0 |
| WHITE BLOOD CELL DECREASED | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 12/818 (1.5%) | 12 | 9/817 (1.1%) | 9 |
| HYPERCALCEMIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| HYPERGLYCEMIA | 6/818 (0.7%) | 6 | 3/817 (0.4%) | 3 |
| HYPERKALEMIA | 0/818 (0%) | 0 | 2/817 (0.2%) | 2 |
| HYPERURICEMIA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| HYPOCALCEMIA | 1/818 (0.1%) | 2 | 0/817 (0%) | 0 |
| HYPOGLYCEMIA | 2/818 (0.2%) | 2 | 4/817 (0.5%) | 4 |
| HYPONATREMIA | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| TUMOR LYSIS SYNDROME | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| ARTHRITIS | 14/818 (1.7%) | 15 | 15/817 (1.8%) | 15 |
| BACK PAIN | 11/818 (1.3%) | 11 | 7/817 (0.9%) | 7 |
| BONE PAIN | 0/818 (0%) | 0 | 2/817 (0.2%) | 2 |
| CHEST WALL PAIN | 1/818 (0.1%) | 1 | 2/817 (0.2%) | 3 |
| GENERALIZED MUSCLE WEAKNESS | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| JOINT EFFUSION | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| JOINT RANGE OF MOTION DECREASED | 1/818 (0.1%) | 1 | 3/817 (0.4%) | 3 |
| JOINT RANGE OF MOTION DECREASED CERVICAL SPINE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| JOINT RANGE OF MOTION DECREASED LUMBAR SPINE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| MUSCLE WEAKNESS LOWER LIMB | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | 9/818 (1.1%) | 9 | 17/817 (2.1%) | 18 |
| MUSCULOSKELETAL DEFORMITY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| MYALGIA | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| MYOSITIS | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 2 |
| NECK PAIN | 4/818 (0.5%) | 4 | 2/817 (0.2%) | 2 |
| OSTEOPOROSIS | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| PAIN IN EXTREMITY | 1/818 (0.1%) | 1 | 8/817 (1%) | 9 |
| SOFT TISSUE NECROSIS UPPER LIMB | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| MYELODYSPLASTIC SYNDROME | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | 24/818 (2.9%) | 31 | 19/817 (2.3%) | 31 |
| Nervous system disorders | ||||
| ATAXIA | 2/818 (0.2%) | 3 | 0/817 (0%) | 0 |
| CENTRAL NERVOUS SYSTEM NECROSIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| CEREBROSPINAL FLUID LEAKAGE | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| COGNITIVE DISTURBANCE | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| DEPRESSED LEVEL OF CONSCIOUSNESS | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| DIZZINESS | 10/818 (1.2%) | 11 | 5/817 (0.6%) | 5 |
| DYSESTHESIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| ENCEPHALOPATHY | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| FACIAL MUSCLE WEAKNESS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| FACIAL NERVE DISORDER | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| HEADACHE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| HYDROCEPHALUS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| INTRACRANIAL HEMORRHAGE | 4/818 (0.5%) | 5 | 3/817 (0.4%) | 4 |
| ISCHEMIA CEREBROVASCULAR | 0/818 (0%) | 0 | 2/817 (0.2%) | 3 |
| LETHARGY | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY | 4/818 (0.5%) | 5 | 1/817 (0.1%) | 1 |
| PERIPHERAL MOTOR NEUROPATHY | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| PERIPHERAL SENSORY NEUROPATHY | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| PRESYNCOPE | 5/818 (0.6%) | 6 | 0/817 (0%) | 0 |
| RADICULITIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| SEIZURE | 3/818 (0.4%) | 4 | 2/817 (0.2%) | 2 |
| STROKE | 15/818 (1.8%) | 19 | 22/817 (2.7%) | 25 |
| SYNCOPE | 13/818 (1.6%) | 15 | 15/817 (1.8%) | 17 |
| TRANSIENT ISCHEMIC ATTACKS | 10/818 (1.2%) | 10 | 8/817 (1%) | 9 |
| TREMOR | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| VASOVAGAL REACTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| Psychiatric disorders | ||||
| ANXIETY | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| CONFUSION | 0/818 (0%) | 0 | 2/817 (0.2%) | 2 |
| DELIRIUM | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| DEPRESSION | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 1 |
| HALLUCINATIONS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| MANIA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| SUICIDE ATTEMPT | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| Renal and urinary disorders | ||||
| ACUTE KIDNEY INJURY | 4/818 (0.5%) | 5 | 4/817 (0.5%) | 4 |
| CHRONIC KIDNEY DISEASE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| HEMATURIA | 1/818 (0.1%) | 1 | 3/817 (0.4%) | 3 |
| PROTEINURIA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| RENAL AND URINARY DISORDERS - OTHER, SPECIFY | 1/818 (0.1%) | 1 | 5/817 (0.6%) | 5 |
| RENAL CALCULI | 3/818 (0.4%) | 3 | 2/817 (0.2%) | 2 |
| URINARY INCONTINENCE | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| URINARY RETENTION | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| URINARY TRACT OBSTRUCTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| URINARY TRACT PAIN | 0/818 (0%) | 0 | 2/817 (0.2%) | 2 |
| Reproductive system and breast disorders | ||||
| PROSTATIC OBSTRUCTION | 2/818 (0.2%) | 2 | 0/817 (0%) | 0 |
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY | 1/818 (0.1%) | 1 | 2/817 (0.2%) | 2 |
| UTERINE PAIN | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| VAGINAL HEMORRHAGE | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| APNEA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| ASPIRATION | 1/818 (0.1%) | 2 | 1/817 (0.1%) | 1 |
| ATELECTASIS | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| BRONCHIAL OBSTRUCTION | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| BRONCHOSPASM | 1/818 (0.1%) | 1 | 2/817 (0.2%) | 2 |
| COUGH | 4/818 (0.5%) | 4 | 1/817 (0.1%) | 1 |
| DYSPNEA | 12/818 (1.5%) | 12 | 7/817 (0.9%) | 8 |
| HICCUPS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| HYPOXIA | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| PLEURAL EFFUSION | 3/818 (0.4%) | 4 | 2/817 (0.2%) | 3 |
| PNEUMONITIS | 17/818 (2.1%) | 23 | 11/817 (1.3%) | 11 |
| PNEUMOTHORAX | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| PRODUCTIVE COUGH | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| PULMONARY FIBROSIS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| PULMONARY HYPERTENSION | 1/818 (0.1%) | 1 | 1/817 (0.1%) | 2 |
| RESPIRATORY FAILURE | 5/818 (0.6%) | 7 | 4/817 (0.5%) | 5 |
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY | 7/818 (0.9%) | 7 | 8/817 (1%) | 9 |
| WHEEZING | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| BULLOUS DERMATITIS | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| RASH MACULO-PAPULAR | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | 2/818 (0.2%) | 2 | 4/817 (0.5%) | 5 |
| SKIN ULCERATION | 0/818 (0%) | 0 | 1/817 (0.1%) | 2 |
| Surgical and medical procedures | ||||
| PROSTECTOMY | 1/818 (0.1%) | 1 | 0/817 (0%) | 0 |
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | 67/818 (8.2%) | 75 | 74/817 (9.1%) | 86 |
| Vascular disorders | ||||
| HEMATOMA | 3/818 (0.4%) | 3 | 0/817 (0%) | 0 |
| HYPERTENSION | 6/818 (0.7%) | 7 | 8/817 (1%) | 8 |
| HYPOTENSION | 8/818 (1%) | 8 | 5/817 (0.6%) | 5 |
| PERIPHERAL ISCHEMIA | 2/818 (0.2%) | 3 | 1/817 (0.1%) | 1 |
| THROMBOEMBOLIC EVENT | 11/818 (1.3%) | 12 | 10/817 (1.2%) | 12 |
| VASCULAR DISORDERS - OTHER, SPECIFY | 5/818 (0.6%) | 6 | 3/817 (0.4%) | 3 |
| VISCERAL ARTERIAL ISCHEMIA | 0/818 (0%) | 0 | 1/817 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Physical Activity | Successful Aging | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 181/818 (22.1%) | 88/817 (10.8%) | ||
| General disorders | ||||
| non-serious AES | 181/818 (22.1%) | 181 | 88/817 (10.8%) | 88 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Michael Miller |
|---|---|
| Organization | Wake Forest School of Medicine |
| Phone | 336-716-6837 |
| mmiller@wakehealth.edu |
- IRB201701066-N
- 3U01AG022376-05A2S1
- U01AG022376