Trial Outcomes & Findings for Nattokinase Atherothrombotic Prevention Study (NCT NCT02080520)
NCT ID: NCT02080520
Last Updated: 2024-03-19
Results Overview
Rate of change in distal common carotid artery (CCA) far wall intima-media thickness (mm per year) in computer image processed B-mode ultrasonograms will be a co-primary trial endpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
265 participants
Primary outcome timeframe
Baseline x 2 and then every 6 months, up to 3 years
Results posted on
2024-03-19
Participant Flow
Participants were recruited from the general population through media campaigns.
1189 individuals were screened by telephone, 857 did not meet inclusion criteria. 332 individuals were screened in research clinic, 67 were excluded (51 did not meet inclusion criteria; 16 declined to participate). 265 individuals were randomized.
Participant milestones
| Measure |
Nattokinase
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
Matching placebo daily
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
133
|
|
Overall Study
COMPLETED
|
118
|
116
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
Reasons for withdrawal
| Measure |
Nattokinase
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
Matching placebo daily
|
|---|---|---|
|
Overall Study
Self-reported symptoms
|
5
|
6
|
|
Overall Study
Unable to contact
|
2
|
1
|
|
Overall Study
Initiated aspirin
|
2
|
0
|
|
Overall Study
Atrial fibrillation
|
1
|
1
|
|
Overall Study
Cancer
|
1
|
2
|
|
Overall Study
Not interested in study
|
1
|
3
|
|
Overall Study
Too busy
|
1
|
1
|
|
Overall Study
Work-related injury
|
1
|
0
|
|
Overall Study
Personal reasons
|
0
|
3
|
Baseline Characteristics
Nattokinase Atherothrombotic Prevention Study
Baseline characteristics by cohort
| Measure |
Nattokinase
n=132 Participants
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 Participants
Matching placebo daily
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
65.4 years
n=5 Participants
|
65.2 years
n=7 Participants
|
65.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
94 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian, non-Hispanic
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
133 participants
n=7 Participants
|
265 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline x 2 and then every 6 months, up to 3 yearsRate of change in distal common carotid artery (CCA) far wall intima-media thickness (mm per year) in computer image processed B-mode ultrasonograms will be a co-primary trial endpoint.
Outcome measures
| Measure |
Nattokinase
n=132 Participants
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 Participants
Matching placebo daily
|
|---|---|---|
|
Progression of Subclinical Atherosclerosis
|
0.013 mm per year
Interval 0.01 to 0.015
|
0.011 mm per year
Interval 0.009 to 0.013
|
PRIMARY outcome
Timeframe: Baseline x 2 and then every 6 months, up to 3 yearsRate of change in arterial distensibility of the distal common carotid artery (CCA) determined from lumen diameters at systole and diastole and systolic and diastolic blood pressure. CCA lumen diameters will be determined from computer image processed B-mode ultrasonograms. This is a co-primary trial endpoint.
Outcome measures
| Measure |
Nattokinase
n=132 Participants
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 Participants
Matching placebo daily
|
|---|---|---|
|
Progression of Carotid Artery Stiffness (Distensibility)
|
-0.501 x(10^-6)(N^-1)(m^2) per year
Interval -0.742 to -0.261
|
-0.389 x(10^-6)(N^-1)(m^2) per year
Interval -0.633 to -0.144
|
PRIMARY outcome
Timeframe: Baseline x 2 and then every 6 months, up to 3 yearsRate of change in arterial compliance of the distal common carotid artery (CCA) determined from lumen diameters at systole and diastole and systolic and diastolic blood pressure. CCA lumen diameters will be determined from computer image processed B-mode ultrasonograms. This is a co-primary trial endpoint.
Outcome measures
| Measure |
Nattokinase
n=132 Participants
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 Participants
Matching placebo daily
|
|---|---|---|
|
Carotid Artery Stiffness Progression (Compliance)
|
-0.019 mm^2/kPa per year
Interval -0.032 to -0.007
|
-0.010 mm^2/kPa per year
Interval -0.023 to 0.002
|
SECONDARY outcome
Timeframe: Baseline and 36 monthsAll neuropsychological test scores at baseline and follow-up assessments were standardized (\[raw score - mean score\]/standard deviation) using the baseline means and standard deviations from the entire NAPS sample. Each of three cognitive composite scores was calculated at baseline (composite score of 0 equals performance at the mean of each test at baseline) and follow-up assessments as the weighted average of the individual donor standardized test scores, weighted by the inverse correlation among tests. The change from baseline (endpoint minus baseline cognitive outcome) was computed for each of the cognitive composite scores (verbal memory, global cognition, and executive functions). Since the outcome is not a single test but a weighted average of multiple tests, the range is not standard and not reported and there is no clinically relevant threshold. A composite score and change in composite score greater than 0 represent better cognitive performance.
Outcome measures
| Measure |
Nattokinase
n=132 Participants
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 Participants
Matching placebo daily
|
|---|---|---|
|
Change in Neurocognitive Function (Global Cognition)
|
0.43 Z-score
Interval 0.22 to 0.63
|
0.43 Z-score
Interval 0.22 to 0.64
|
Adverse Events
Nattokinase
Serious events: 13 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 15 serious events
Other events: 57 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nattokinase
n=132 participants at risk
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 participants at risk
Matching placebo daily
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Non-fatal myocardial infarction
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Chest pain
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Coronary artery bypass graft surgery
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast ductal carcinoma in-situ
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast invasive ductal carcinoma
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.0%
4/132 • Number of events 4 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Perforated appendicitis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Diverticulosis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Benign tumor excision
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
Other adverse events
| Measure |
Nattokinase
n=132 participants at risk
Oral nattokinase 2,000 fibrinolytic units daily
|
Placebo
n=133 participants at risk
Matching placebo daily
|
|---|---|---|
|
Investigations
Biopsy breast
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Blood and lymphatic system disorders
Thymic cyst
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Chest pain
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Ear and labyrinth disorders
Vertigo
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Eye disorders
Cataract
|
0.76%
1/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Eye disorders
Vision blurred
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
2.3%
3/133 • Number of events 3 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Nausea
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Gastrointestinal disorders
Colon polyps
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
General disorders
Chest pain
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
General disorders
Peripheral swelling
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Bronchitis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Diverticulitis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Herpes zoster
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Pyelonephritis acute
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
2.3%
3/133 • Number of events 3 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Dermatitis contact
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
2.3%
3/133 • Number of events 3 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.76%
1/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Angiogram
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Arteriogram coronary
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Arthroscopy
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Biopsy
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Biopsy colon
|
0.76%
1/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Biopsy prostate
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Biopsy skin
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Biopsy thyroid gland
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Colonoscopy
|
2.3%
3/132 • Number of events 3 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Investigations
Weight increased
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
3/132 • Number of events 3 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.0%
4/132 • Number of events 6 • Adverse event data were collected for up to 3 years for each participant.
|
3.0%
4/133 • Number of events 4 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Cognitive disorder
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Dizziness
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Headache
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Hypoaesthesia
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Nervous system disorders
Parkinson's disease
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Psychiatric disorders
Confusional state
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Psychiatric disorders
Libido decreased
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Renal and urinary disorders
Ureterolithiasis and Nephrolithiasis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Reproductive system and breast disorders
Hot flush
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Apicoectomy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Bunion and toe operation
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Cataract operation
|
2.3%
3/132 • Number of events 4 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Dental implantation
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Dupuytren's contracture operation
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Eyelid operation
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Femoral hernia repair
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
1.5%
2/133 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Prostatic radiotherapies
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Rotator cuff repair
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Surgery, hernia
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Suture insertion
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Trapeziectomy
|
0.76%
1/132 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
2/132 • Number of events 2 • Adverse event data were collected for up to 3 years for each participant.
|
0.00%
0/133 • Adverse event data were collected for up to 3 years for each participant.
|
|
Vascular disorders
Haematoma
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
|
Vascular disorders
Hypertension
|
0.00%
0/132 • Adverse event data were collected for up to 3 years for each participant.
|
0.75%
1/133 • Number of events 1 • Adverse event data were collected for up to 3 years for each participant.
|
Additional Information
Howard N. Hodis, M.D.
Atherosclerosis Research Unit, University of Southern California
Phone: 323-442-1478
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place