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Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation (AREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02283294
Recruitment Status : Completed
First Posted : November 5, 2014
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Transient Ischemic Attack
Stroke
Atrial Fibrillation
Interventions Drug: Apixaban
Drug: Warfarin
Enrollment 91
Recruitment Details  
Pre-assignment Details Ninety one patients were enrolled/consented into the study. Three patients of the 91 consented did not meet one or more of the inclusion/exclusion criteria and were excluded prior to randomization assignment.
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description

Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively

Apixaban

standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).

Warfarin

Period Title: Overall Study
Started [1] 41 47
Received Allocated Treatment Intervention 38 31
Completed 38 39
Not Completed 3 8
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             6
Protocol Violation             1             0
Thrombus on transesophageal echocardiogram             0             1
[1]
Started indicates randomized to medication assignment. This does not necessarily indicate patient started the medication they were randomized to.
Arm/Group Title Apixaban Warfarin Total
Hide Arm/Group Description

Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively

Apixaban

standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).

Warfarin

Total of all reporting groups
Overall Number of Baseline Participants 41 47 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  31.7%
12
  25.5%
25
  28.4%
>=65 years
28
  68.3%
35
  74.5%
63
  71.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 47 participants 88 participants
72.6  (14.9) 74.3  (10.5) 73.5  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
Female
26
  63.4%
23
  48.9%
49
  55.7%
Male
15
  36.6%
24
  51.1%
39
  44.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
Black
7
  17.1%
5
  10.6%
12
  13.6%
Hispanic
3
   7.3%
6
  12.8%
9
  10.2%
Non-Hispanic White
31
  75.6%
35
  74.5%
66
  75.0%
Other
0
   0.0%
1
   2.1%
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 47 participants 88 participants
41 47 88
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
38
  92.7%
46
  97.9%
84
  95.5%
Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
24
  58.5%
34
  72.3%
58
  65.9%
Coronary artery disease (CAD)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
13
  31.7%
18
  38.3%
31
  35.2%
[1]
Measure Description: Inclusive of history of untreated myocardial infarction, prior stenting, and prior coronary artery bypass graft. Does not include non-obstructive coronary disease.
Diabetes Mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
10
  24.4%
22
  46.8%
32
  36.4%
Peripheral Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
4
   9.8%
9
  19.1%
13
  14.8%
Prior Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
9
  22.0%
10
  21.3%
19
  21.6%
Prosthetic Heart Valve / Valve Replacement  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
1
   2.4%
4
   8.5%
5
   5.7%
Thyroid Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
9
  22.0%
13
  27.7%
22
  25.0%
Obstructive Sleep Apnea  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
5
  12.2%
7
  14.9%
12
  13.6%
Congestive Heart Failure Symptoms  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
3
   7.3%
9
  19.1%
12
  13.6%
Past Medical History Left Ventricular Ejection Fraction < 40%  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
6
  14.6%
13
  27.7%
19
  21.6%
Chronic Kidney Disease Stage 3   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
7
  17.1%
15
  31.9%
22
  25.0%
[1]
Measure Description: glomerular filtration rate 30-59 mL/min/1.73 m^2
Chronic Kidney Disease Stage 4   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
1
   2.4%
2
   4.3%
3
   3.4%
[1]
Measure Description: glomerular filtration rate 15-29 mL/min/1.73 m^2
Chronic Kidney Disease Stage 5   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: glomerular filtration rate <15 or on dialysis
Transient Ischemic Attack  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
4
   9.8%
3
   6.4%
7
   8.0%
Thromboembolism History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
0
   0.0%
3
   6.4%
3
   3.4%
New Onset Atrial Fibrillation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
14
  34.1%
14
  29.8%
28
  31.8%
Prior Use of Anticoagulation within last 3 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
3
   7.3%
11
  23.4%
14
  15.9%
Former Tobacco Use History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
10
  24.4%
13
  27.7%
23
  26.1%
Former Alcohol Use History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
1
   2.4%
2
   4.3%
3
   3.4%
Former Illegal Drug Use History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
1
   2.4%
1
   2.1%
2
   2.3%
Height  
Mean (Standard Deviation)
Unit of measure:  m
Number Analyzed 41 participants 47 participants 88 participants
1.67  (0.11) 1.712  (0.14) 1.69  (0.13)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 41 participants 47 participants 88 participants
82.10  (24.09) 88.08  (24.73) 85.29  (24.48)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 41 participants 47 participants 88 participants
29.15  (6.68) 30.05  (7.60) 29.63  (7.16)
Body Surface Area  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 41 participants 47 participants 88 participants
1.90  (0.28) 1.99  (0.31) 1.95  (0.30)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Bpm
Number Analyzed 41 participants 47 participants 88 participants
76.56  (14.46) 76.62  (16.61) 76.60  (15.56)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 41 participants 47 participants 88 participants
130.85  (18.64) 134.53  (20.13) 132.82  (19.43)
Current Tobacco Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
0
   0.0%
4
   8.5%
4
   4.5%
[1]
Measure Description: Daily Use
Occasional Tobacco Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Less than daily user
Current Alcohol Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
6
  14.6%
6
  12.8%
12
  13.6%
[1]
Measure Description: >/= 1 drink per day (1 drink = 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits)
Occasional Alcohol Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 47 participants 88 participants
9
  22.0%
8
  17.0%
17
  19.3%
[1]
Measure Description: <1 drink per day (1 drink = 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 41 participants 47 participants 88 participants
74.07  (17.76) 70.26  (19.50) 72.03  (18.70)
1.Primary Outcome
Title Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA
Hide Description [Not Specified]
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description:

Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively

Apixaban

Standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).

Warfarin

Overall Number of Participants Analyzed 41 47
Measure Type: Count of Participants
Unit of Measure: Participants
7
  17.1%
12
  25.5%
2.Secondary Outcome
Title Number of Participants With an Intracranial Hemorrhage Assessed by MRI/CT
Hide Description [Not Specified]
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description:

Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively

Apixaban

standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).

Warfarin

Overall Number of Participants Analyzed 41 47
Measure Type: Count of Participants
Unit of Measure: Participants
5
  12.2%
6
  12.8%
Time Frame 210 +/- 10 days
Adverse Event Reporting Description Adverse event assessment was performed at each of the patient follow up visits at baseline, day 14, day 30, day 60, day 120, day 150, day 180, and day 210. At each follow up visit, patients were evaluated by study coordinator, cardiologist, and neurologist. A physical exam, patient interview, electrocardiogram, and review of patient records were performed. Labs were evaluated for clinical significance at day 30, day 90, and day 180 visits.
 
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description

Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively

Apixaban

standard of care warfarin starting at day 7±5 (TIA) or day 14 ±5 (small to medium ischemic stroke).

Warfarin

All-Cause Mortality
Apixaban Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   2/41 (4.88%)      4/47 (8.51%)    
Hide Serious Adverse Events
Apixaban Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/41 (26.83%)      14/47 (29.79%)    
Blood and lymphatic system disorders     
Symptomatic Anemia   1/41 (2.44%)  1 0/47 (0.00%)  0
Cardiac disorders     
Third Degree AV Block *  0/41 (0.00%)  0 2/47 (4.26%)  2
Worsening Congestive Heart Failure   2/41 (4.88%)  2 0/47 (0.00%)  0
Worsening Atrial Fibrillation   1/41 (2.44%)  1 2/47 (4.26%)  2
Symptomatic Hypotension   1/41 (2.44%)  1 0/47 (0.00%)  0
Endocrine disorders     
Pancreatic Cancer *  1/41 (2.44%)  1 0/47 (0.00%)  0
Gastrointestinal disorders     
GI Bleed   0/41 (0.00%)  0 1/47 (2.13%)  1
Small Bowel Obstruction   1/41 (2.44%)  1 0/47 (0.00%)  0
Pancolitis   0/41 (0.00%)  0 2/47 (4.26%)  2
General disorders     
Fatal Stroke *  1/41 (2.44%)  1 3/47 (6.38%)  3
Symptomatic PH1 Hemorrhagic Transformation   0/41 (0.00%)  0 1/47 (2.13%)  1
TIA   1/41 (2.44%)  1 2/47 (4.26%)  2
Acute Encephalopathy   1/41 (2.44%)  1 0/47 (0.00%)  0
Recurrent Stroke   5/41 (12.20%)  5 7/47 (14.89%)  7
Altered Mental Status   0/41 (0.00%)  0 1/47 (2.13%)  1
Metabolic Encephalopathy   1/41 (2.44%)  1 0/47 (0.00%)  0
Shortness of Breath   0/41 (0.00%)  0 1/47 (2.13%)  1
Musculoskeletal and connective tissue disorders     
Left Hip Fracture   0/41 (0.00%)  0 1/47 (2.13%)  1
Rhabdomyolysis   1/41 (2.44%)  1 0/47 (0.00%)  0
Second Digit Right Foot Amputation   0/41 (0.00%)  0 1/47 (2.13%)  1
Back Fracture   0/41 (0.00%)  0 1/47 (2.13%)  1
Worsening Back Pain   0/41 (0.00%)  0 1/47 (2.13%)  1
Bilateral Leg Weakness / Trouble with Ambulation   0/41 (0.00%)  0 1/47 (2.13%)  1
Right Hip Pain   0/41 (0.00%)  0 1/47 (2.13%)  1
Ostectomy Left Foot   0/41 (0.00%)  0 1/47 (2.13%)  1
Reproductive system and breast disorders     
Ovarian Cyst   1/41 (2.44%)  1 0/47 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Apixaban Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/41 (87.80%)      41/47 (87.23%)    
Blood and lymphatic system disorders     
Leukocytosis   0/41 (0.00%)  0 1/47 (2.13%)  1
Cardiac disorders     
Fatigue   5/41 (12.20%)  5 5/47 (10.64%)  5
Dizziness   2/41 (4.88%)  2 9/47 (19.15%)  10
Shortness of Breath   2/41 (4.88%)  2 4/47 (8.51%)  4
Sinus Bradycardia   0/41 (0.00%)  0 1/47 (2.13%)  1
Bilateral Lower Extremity Edema   10/41 (24.39%)  11 3/47 (6.38%)  4
Hypertension   1/41 (2.44%)  1 1/47 (2.13%)  1
Palpitations   0/41 (0.00%)  0 1/47 (2.13%)  1
Blood Clot in Descending Aorta   0/41 (0.00%)  0 1/47 (2.13%)  1
Pleuritic Chest Pain   0/41 (0.00%)  0 1/47 (2.13%)  1
Chest Pain or Tightness   6/41 (14.63%)  6 3/47 (6.38%)  4
Intermittent Cardiac Pauses   1/41 (2.44%)  1 0/47 (0.00%)  0
Supratherapeutic INR   0/41 (0.00%)  0 9/47 (19.15%)  29
Hypotension   0/41 (0.00%)  0 2/47 (4.26%)  2
Bradycardia   0/41 (0.00%)  0 1/47 (2.13%)  1
Orthostatic Loss of Consciousness   1/41 (2.44%)  1 0/47 (0.00%)  0
Nonsustained Ventricular Tachycardia   1/41 (2.44%)  1 0/47 (0.00%)  0
Supraventricular Tachycardia   1/41 (2.44%)  1 0/47 (0.00%)  0
Pacemaker Implant for Arrhythmia   0/41 (0.00%)  0 1/47 (2.13%)  1
Tachycardia   0/41 (0.00%)  0 1/47 (2.13%)  1
Thrombus in Appendage   0/41 (0.00%)  0 1/47 (2.13%)  1
Fluid Overload   0/41 (0.00%)  0 1/47 (2.13%)  1
Heart Failure with Preserved Ejection Fraction   0/41 (0.00%)  0 1/47 (2.13%)  1
Eye disorders     
Left Eye Subconjunctival Hemorrhage   0/41 (0.00%)  0 1/47 (2.13%)  1
Diploplia   0/41 (0.00%)  0 1/47 (2.13%)  1
Gastrointestinal disorders     
Vomiting   3/41 (7.32%)  3 5/47 (10.64%)  6
Diarrhea   2/41 (4.88%)  2 2/47 (4.26%)  2
Constipation   1/41 (2.44%)  1 1/47 (2.13%)  1
Decreased Appetite   0/41 (0.00%)  0 1/47 (2.13%)  1
Nausea   2/41 (4.88%)  2 1/47 (2.13%)  1
Gastrointestinal Upset   0/41 (0.00%)  0 1/47 (2.13%)  1
Esophagitis   0/41 (0.00%)  0 1/47 (2.13%)  1
Gastrointestinal Bleed   1/41 (2.44%)  2 0/47 (0.00%)  0
Acute Gastric Ulcer with Hemorrhage   1/41 (2.44%)  1 0/47 (0.00%)  0
Abdominal Distention   0/41 (0.00%)  0 1/47 (2.13%)  2
Viral Illness   1/41 (2.44%)  1 0/47 (0.00%)  0
Gastritis   0/41 (0.00%)  0 1/47 (2.13%)  1
General disorders     
Intermittent Headaches   5/41 (12.20%)  5 5/47 (10.64%)  5
Asymptomatic Bleed   5/41 (12.20%)  5 5/47 (10.64%)  5
Fever   1/41 (2.44%)  1 0/47 (0.00%)  0
Difficulty Finding Words   2/41 (4.88%)  2 0/47 (0.00%)  0
Intermittent Cognitive Impairment   3/41 (7.32%)  3 2/47 (4.26%)  2
Cough   2/41 (4.88%)  2 2/47 (4.26%)  3
Dry Mouth   1/41 (2.44%)  1 0/47 (0.00%)  0
Altered Sense of Taste   1/41 (2.44%)  1 1/47 (2.13%)  1
Cold Symptoms   1/41 (2.44%)  1 2/47 (4.26%)  2
Sore Throat   0/41 (0.00%)  0 1/47 (2.13%)  1
Worsening Hearing Loss   1/41 (2.44%)  1 0/47 (0.00%)  0
Ataxia   0/41 (0.00%)  0 1/47 (2.13%)  1
Right or Left Sided Weakness   2/41 (4.88%)  2 1/47 (2.13%)  1
Shakiness   0/41 (0.00%)  0 1/47 (2.13%)  1
Intermittent Lightheadedness   2/41 (4.88%)  2 1/47 (2.13%)  1
Bronchitis   3/41 (7.32%)  3 1/47 (2.13%)  1
Generalized Weakness   1/41 (2.44%)  1 1/47 (2.13%)  1
Hemoptysis   0/41 (0.00%)  0 1/47 (2.13%)  1
Hyponatremia   0/41 (0.00%)  0 1/47 (2.13%)  1
Hypokalemia   1/41 (2.44%)  1 0/47 (0.00%)  0
Hyperkalemia   1/41 (2.44%)  1 0/47 (0.00%)  0
Left Lower Facial Numbness   1/41 (2.44%)  1 0/47 (0.00%)  0
Parathesia   1/41 (2.44%)  1 0/47 (0.00%)  0
Vertigo   1/41 (2.44%)  1 0/47 (0.00%)  0
Sinus Infection   0/41 (0.00%)  0 1/47 (2.13%)  1
Diaphoretic   1/41 (2.44%)  1 0/47 (0.00%)  0
Responsive Only to Painful Stimuli   1/41 (2.44%)  1 0/47 (0.00%)  0
Slurred Speech   1/41 (2.44%)  1 0/47 (0.00%)  0
Blood in Sputum   0/41 (0.00%)  0 1/47 (2.13%)  1
Motor Vehicle Accident with Injury   0/41 (0.00%)  0 1/47 (2.13%)  1
White Tongue   0/41 (0.00%)  0 1/47 (2.13%)  1
Generalized Body Numbness   0/41 (0.00%)  0 1/47 (2.13%)  1
Syncopal Episode   1/41 (2.44%)  1 0/47 (0.00%)  0
Dehydration   0/41 (0.00%)  0 1/47 (2.13%)  1
Hepatobiliary disorders     
Abnormal Liver Tests   1/41 (2.44%)  1 0/47 (0.00%)  0
Total Bilirubin Elevated   1/41 (2.44%)  1 0/47 (0.00%)  0
Infections and infestations     
Staph Infection Right Foot   0/41 (0.00%)  0 1/47 (2.13%)  1
Ear and Nose Infection   0/41 (0.00%)  0 1/47 (2.13%)  1
Bladder Infection   0/41 (0.00%)  0 1/47 (2.13%)  1
Musculoskeletal and connective tissue disorders     
Back Pain   1/41 (2.44%)  1 3/47 (6.38%)  3
Intermittent Leg Cramping   1/41 (2.44%)  1 0/47 (0.00%)  0
Body / Muscle Aches   1/41 (2.44%)  1 3/47 (6.38%)  3
Back Pain with Ambulation   0/41 (0.00%)  0 1/47 (2.13%)  1
Right Hip Pain   0/41 (0.00%)  0 1/47 (2.13%)  1
Left Calf Sore   1/41 (2.44%)  1 0/47 (0.00%)  0
Lower Back Pain   1/41 (2.44%)  1 0/47 (0.00%)  0
Gout Right Foot   1/41 (2.44%)  1 0/47 (0.00%)  0
Fall without Injury   7/41 (17.07%)  9 3/47 (6.38%)  3
Left Foot Pain   2/41 (4.88%)  2 1/47 (2.13%)  1
Unsteady Gait   2/41 (4.88%)  2 0/47 (0.00%)  0
Intermittent Left Leg Pain   1/41 (2.44%)  1 0/47 (0.00%)  0
Left Ankle Swelling   1/41 (2.44%)  1 0/47 (0.00%)  0
Right Ankle Pain   1/41 (2.44%)  1 0/47 (0.00%)  0
Right Foot Droop   0/41 (0.00%)  0 1/47 (2.13%)  1
Sensory Peripheral Neuropathy   0/41 (0.00%)  0 1/47 (2.13%)  1
Fall with Injury   4/41 (9.76%)  4 2/47 (4.26%)  2
Facial and Neck Swelling   1/41 (2.44%)  1 0/47 (0.00%)  0
Bilateral Lower Extremity Pain   1/41 (2.44%)  1 0/47 (0.00%)  0
Muscle Spasticity   1/41 (2.44%)  1 0/47 (0.00%)  0
Upper Extremity Stiffness   1/41 (2.44%)  1 0/47 (0.00%)  0
Left Lower Extremity Edema   1/41 (2.44%)  1 0/47 (0.00%)  0
Left Middle Finger Pain   1/41 (2.44%)  1 0/47 (0.00%)  0
Minor Head Injury   0/41 (0.00%)  0 1/47 (2.13%)  1
Right Great Toenail Removal Status Post Toe Injury   0/41 (0.00%)  0 1/47 (2.13%)  1
Left Hamstring Injury   0/41 (0.00%)  0 1/47 (2.13%)  1
Right Flank Pain   0/41 (0.00%)  0 1/47 (2.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Small Benign Cysts, Right Hepatic Lobe   1/41 (2.44%)  1 0/47 (0.00%)  0
Midpelvic Mass   1/41 (2.44%)  1 0/47 (0.00%)  0
Renal and urinary disorders     
Urinary Tract Infection   6/41 (14.63%)  6 3/47 (6.38%)  3
Acute Kidney Injury   1/41 (2.44%)  1 1/47 (2.13%)  1
Erectile Dysfunction   1/41 (2.44%)  1 1/47 (2.13%)  1
Vaginal Bleeding   2/41 (4.88%)  3 0/47 (0.00%)  0
Acute Renal Failure   1/41 (2.44%)  1 0/47 (0.00%)  0
Hematuria   1/41 (2.44%)  1 0/47 (0.00%)  0
Blood in Semen   0/41 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection   2/41 (4.88%)  2 0/47 (0.00%)  0
Pneumonia   1/41 (2.44%)  1 2/47 (4.26%)  2
Pulmonary Edema   0/41 (0.00%)  0 1/47 (2.13%)  1
Bibasilar Rales   1/41 (2.44%)  1 0/47 (0.00%)  0
Chronic Obstructive Pulmonary Disease Exacerbation   0/41 (0.00%)  0 1/47 (2.13%)  1
Coarse Breath Sounds   0/41 (0.00%)  0 1/47 (2.13%)  1
Wheezing   1/41 (2.44%)  1 2/47 (4.26%)  2
Skin and subcutaneous tissue disorders     
Left Foot Cellulitis   0/41 (0.00%)  0 1/47 (2.13%)  1
Bruising   1/41 (2.44%)  2 8/47 (17.02%)  12
Abrasions   1/41 (2.44%)  1 6/47 (12.77%)  8
Right Chest Basal Cell Removal   1/41 (2.44%)  1 0/47 (0.00%)  0
Upper Left Back Basal Cell Removal   1/41 (2.44%)  1 0/47 (0.00%)  0
Right Temporal Laceration   1/41 (2.44%)  1 0/47 (0.00%)  0
Scalp Hematoma   0/41 (0.00%)  0 1/47 (2.13%)  1
Actinic Keratosis Left Forearm   1/41 (2.44%)  1 0/47 (0.00%)  0
Squamous Cell Carcinoma   1/41 (2.44%)  1 0/47 (0.00%)  0
Skin Peeling   0/41 (0.00%)  0 1/47 (2.13%)  1
Skin Lesion to Nose   0/41 (0.00%)  0 1/47 (2.13%)  1
Right Lower Extremity Blister   0/41 (0.00%)  0 1/47 (2.13%)  1
Bilateral Lower Extremity Dermatitis   0/41 (0.00%)  0 1/47 (2.13%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: David Rose, MD
Organization: University of South Florida
Phone: 813-259-8577
EMail: drose1@usf.edu
Layout table for additonal information
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02283294    
Other Study ID Numbers: PRO00019754
First Submitted: October 29, 2014
First Posted: November 5, 2014
Results First Submitted: July 7, 2021
Results First Posted: November 30, 2021
Last Update Posted: November 30, 2021