Trial Outcomes & Findings for Observational Study of OCT in a Patients Undergoing FFR (NCT NCT01663896)
NCT ID: NCT01663896
Last Updated: 2020-07-02
Results Overview
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
Recruitment status
COMPLETED
Target enrollment
418 participants
Primary outcome timeframe
In-hospital until discharge
Results posted on
2020-07-02
Participant Flow
Initially a total of 1069 subjects gave consent from 36 investigational sites, of which 418 qualified subjects completed enrollment in February 2014 at 35 investigational sites. First subject was enrolled on Dec 11, 2012 and the last subject completed the 12 month follow-up on Mar 12, 2015.
Of the 1069 subjects, 616 were failed to screen and 35 were not qualified for inclusion. Thus 418 subjects underwent pre-intervention fractional flow reserve (FFR) and optical coherence tomography (OCT), percutaneous coronary intervention (PCI), and post intervention FFR and OCT. The subjects were followed up through 12 month post stent implant.
Participant milestones
| Measure |
Optical Coherence Tomography (OCT)
Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
|
|---|---|
|
Overall Study
STARTED
|
418
|
|
Overall Study
COMPLETED
|
375
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Optical Coherence Tomography (OCT)
Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
|
|---|---|
|
Overall Study
Various reasons
|
43
|
Baseline Characteristics
Observational Study of OCT in a Patients Undergoing FFR
Baseline characteristics by cohort
| Measure |
Optical Coherence Tomography (OCT)
n=418 Participants
Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
|
|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
314 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
97 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: In-hospital until dischargeIncidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
Outcome measures
| Measure |
Optical Coherence Tomography (OCT)
n=418 Participants
A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
|
|---|---|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Very Late)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE (Cardiac death)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE(MI-AEC definition)
|
6.7 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE(MI-3rd Universal definition)
|
6.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE(TLR)
|
0.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(All-cause mortality)
|
0.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(MI-ARC Definition)
|
6.7 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(MI-3rd Universal definition)
|
6.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(Any Revascularization)
|
0.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Definite)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Probable)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Possible)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Early)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Late)
|
0 Percentage of per-subject incidence
|
PRIMARY outcome
Timeframe: 30 DaysIncidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
Outcome measures
| Measure |
Optical Coherence Tomography (OCT)
n=416 Participants
A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
|
|---|---|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE (Cardiac death)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE(MI-AEC definition)
|
7.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE(MI-3rd Universal definition)
|
6.7 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Device-oriented MACE(TLR)
|
0.7 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(MI-3rd Universal definition)
|
7.5 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(Any Revascularization)
|
1.7 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(All-cause mortality)
|
0.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Patient-oriented MACE(MI-ARC Definition)
|
7.9 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Definite)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Probable)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Possible)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Early)
|
0.2 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Late)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Stent Thrombosis(Very Late)
|
0 Percentage of per-subject incidence
|
PRIMARY outcome
Timeframe: 12 monthsIncidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
Outcome measures
| Measure |
Optical Coherence Tomography (OCT)
n=399 Participants
A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
|
|---|---|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Patient-oriented MACE(All-cause mortality)
|
1.8 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Patient-oriented MACE(MI-ARC Definition)
|
9.3 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Stent Thrombosis(Definite)
|
0.3 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Stent Thrombosis(Probable)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Stent Thrombosis(Early)
|
0.3 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Stent Thrombosis(Late)
|
0.5 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Stent Thrombosis(Very Late)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Device-oriented MACE (Cardiac death)
|
0 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Device-oriented MACE(MI-AEC definition)
|
8.3 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Device-oriented MACE(MI-3rd Universal definition)
|
7.8 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Device-oriented MACE(TLR)
|
2.5 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Patient-oriented MACE(MI-3rd Universal definition)
|
8.8 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Patient-oriented MACE(Any Revascularization)
|
5.5 Percentage of per-subject incidence
|
|
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Stent Thrombosis(Possible)
|
0.5 Percentage of per-subject incidence
|
SECONDARY outcome
Timeframe: 1 YearAssessment of OCT on Physician Decision Making includes: * Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment * OCT parameters as assessed by Core Lab
Outcome measures
| Measure |
Optical Coherence Tomography (OCT)
n=418 Participants
A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
|
|---|---|
|
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Procedure Planning(Pre-PCI OCT)
|
57 Percentage of participants
|
|
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Procedure Planning(Post-PCI OCT)
|
27 Percentage of participants
|
|
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Physician decision-making (Pre-PCI OCT)
|
65 Percentage of participants
|
|
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Physician decision-making (Post-PCI OCT)
|
65 Percentage of participants
|
Adverse Events
Optical Coherence Tomography (OCT)
Serious events: 112 serious events
Other events: 128 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Optical Coherence Tomography (OCT)
n=418 participants at risk
Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.24%
1/418 • 1-Year
|
|
Investigations
Abnormal Lab Value
|
0.48%
2/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Acute Erosive Gastritis
|
0.24%
1/418 • 1-Year
|
|
Blood and lymphatic system disorders
Anemias
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Angina Pectoris
|
0.24%
1/418 • 1-Year
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Arterial Hypertension/Hypertension
|
0.48%
2/418 • 1-Year
|
|
General disorders
Ascites
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.72%
3/418 • 1-Year
|
|
Cardiac disorders
Atrial Flutter
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Atrioventricular (AV) Dissociation
|
0.24%
1/418 • 1-Year
|
|
Blood and lymphatic system disorders
Bleeding
|
0.48%
2/418 • 1-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.48%
2/418 • 1-Year
|
|
Cardiac disorders
Cardiac Arrest
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Cardiomyopathy
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Cardiovascular Deconditioning
|
0.24%
1/418 • 1-Year
|
|
General disorders
Chest Pain
|
5.7%
24/418 • 1-Year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.24%
1/418 • 1-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.48%
2/418 • 1-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Polyps
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Coronary Artery Disease
|
0.48%
2/418 • 1-Year
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Diarrhea
|
0.24%
1/418 • 1-Year
|
|
General disorders
Discomfort
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.24%
1/418 • 1-Year
|
|
Investigations
EKG Abnormalities
|
0.24%
1/418 • 1-Year
|
|
Investigations
Echo Finding
|
0.24%
1/418 • 1-Year
|
|
Surgical and medical procedures
Elective Surgery
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Emesis/Vomiting
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.4%
6/418 • 1-Year
|
|
General disorders
Gingival Bleeding
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Heart Failure
|
0.48%
2/418 • 1-Year
|
|
General disorders
Hematochezia
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Hematoma
|
1.2%
5/418 • 1-Year
|
|
Renal and urinary disorders
Hematuria
|
0.24%
1/418 • 1-Year
|
|
Investigations
Hyperkalemia
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Hypotension
|
0.48%
2/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Interstitial Lung Diseases
|
0.24%
1/418 • 1-Year
|
|
Infections and infestations
Influenza
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Intracerebral Haemorrhage
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Ischemic Stroke
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Left Bundle Branch Block/Complete Left Bundle Branch Block
|
0.24%
1/418 • 1-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.24%
1/418 • 1-Year
|
|
General disorders
Melena
|
0.48%
2/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Myocardial Infarction
|
1.9%
8/418 • 1-Year
|
|
General disorders
Non-Cardiac Chest Pain
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Non-Endpoint Transient Ischemic Attack (TIA)
|
0.24%
1/418 • 1-Year
|
|
General disorders
Other
|
3.3%
14/418 • 1-Year
|
|
Cardiac disorders
Pericardial Tamponade
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.24%
1/418 • 1-Year
|
|
Infections and infestations
Pneumonia
|
0.48%
2/418 • 1-Year
|
|
Infections and infestations
Pneumonia in the Compromised Host
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Presyncope
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Radiculopathy
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.24%
1/418 • 1-Year
|
|
Injury, poisoning and procedural complications
Side Branch Compromise
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Stroke
|
0.48%
2/418 • 1-Year
|
|
Nervous system disorders
Syncope
|
0.48%
2/418 • 1-Year
|
|
Cardiac disorders
Third Degree Heart Block (Complete Heart Block)
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Unstable Angina
|
0.72%
3/418 • 1-Year
|
|
Vascular disorders
VASC Vessel Stenosis
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.48%
2/418 • 1-Year
|
|
Vascular disorders
Vessel Stenosis
|
2.4%
10/418 • 1-Year
|
|
Eye disorders
Visual Disturbance
|
0.24%
1/418 • 1-Year
|
Other adverse events
| Measure |
Optical Coherence Tomography (OCT)
n=418 participants at risk
Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
|
|---|---|
|
General disorders
Abdominal Pain
|
0.24%
1/418 • 1-Year
|
|
Investigations
Abnormal Lab Value
|
0.24%
1/418 • 1-Year
|
|
General disorders
Abrasion
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.24%
1/418 • 1-Year
|
|
Immune system disorders
Allergy
|
0.24%
1/418 • 1-Year
|
|
Blood and lymphatic system disorders
Anemias
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Angina Pectoris
|
0.24%
1/418 • 1-Year
|
|
Psychiatric disorders
Anxiety
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Aortic Aneurysms
|
0.24%
1/418 • 1-Year
|
|
General disorders
Apnea
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Arm Fracture
|
0.48%
2/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Arterial Hypertension/Hypertension
|
1.2%
5/418 • 1-Year
|
|
Vascular disorders
Arteriovenous (AV) Fistula
|
0.24%
1/418 • 1-Year
|
|
Infections and infestations
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.24%
1/418 • 1-Year
|
|
General disorders
Back Pain
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Bleeding
|
0.48%
2/418 • 1-Year
|
|
Eye disorders
Blurred Vision
|
0.24%
1/418 • 1-Year
|
|
Skin and subcutaneous tissue disorders
Bruise/Purpura Simplex
|
0.48%
2/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.24%
1/418 • 1-Year
|
|
General disorders
Callus
|
0.24%
1/418 • 1-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Carpal Tunnel
|
0.24%
1/418 • 1-Year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.24%
1/418 • 1-Year
|
|
General disorders
Chest Pain
|
4.3%
18/418 • 1-Year
|
|
General disorders
Chest Tightness
|
0.96%
4/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.96%
4/418 • 1-Year
|
|
Renal and urinary disorders
Chronic Renal Failure
|
0.24%
1/418 • 1-Year
|
|
Infections and infestations
Common Cold/Upper Respiratory Tract Infection
|
1.4%
6/418 • 1-Year
|
|
Eye disorders
Conjunctivitis
|
0.48%
2/418 • 1-Year
|
|
Gastrointestinal disorders
Constipation
|
0.72%
3/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.72%
3/418 • 1-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.24%
1/418 • 1-Year
|
|
Psychiatric disorders
Depression
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Diarrhea
|
0.48%
2/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Catching Breath
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Diverticulitis
|
0.24%
1/418 • 1-Year
|
|
Ear and labyrinth disorders
Dizziness
|
1.2%
5/418 • 1-Year
|
|
Eye disorders
Dry Eyes
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Dysphagia
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
14/418 • 1-Year
|
|
Renal and urinary disorders
Dysuria
|
0.24%
1/418 • 1-Year
|
|
Investigations
EKG Abnormalities
|
0.96%
4/418 • 1-Year
|
|
General disorders
Edema
|
0.72%
3/418 • 1-Year
|
|
Eye disorders
Eye Infection
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Fainting/Blackout
|
0.24%
1/418 • 1-Year
|
|
General disorders
Fatigue/Generalized Fatigue
|
2.4%
10/418 • 1-Year
|
|
Infections and infestations
Fever
|
0.72%
3/418 • 1-Year
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Headache
|
0.72%
3/418 • 1-Year
|
|
Vascular disorders
Hematoma
|
0.24%
1/418 • 1-Year
|
|
Renal and urinary disorders
Hematuria
|
0.96%
4/418 • 1-Year
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.24%
1/418 • 1-Year
|
|
General disorders
Hip Pain
|
1.2%
5/418 • 1-Year
|
|
Endocrine disorders
Hyperglycemia
|
0.48%
2/418 • 1-Year
|
|
Investigations
Hypokalemia
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Hypokinetic Septal Motion
|
0.24%
1/418 • 1-Year
|
|
Investigations
Hyponatremia
|
0.24%
1/418 • 1-Year
|
|
Gastrointestinal disorders
Ingestion
|
0.24%
1/418 • 1-Year
|
|
Blood and lymphatic system disorders
Iron-Deficiency Anemia
|
0.24%
1/418 • 1-Year
|
|
General disorders
Knee Pain
|
1.2%
5/418 • 1-Year
|
|
General disorders
Lacerations
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.96%
4/418 • 1-Year
|
|
General disorders
Melena
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Mitral Valve Regurgitation/Mitral Insufficiency
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Muscle Strain
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.2%
5/418 • 1-Year
|
|
General disorders
Myalgias
|
0.24%
1/418 • 1-Year
|
|
General disorders
Nausea
|
0.24%
1/418 • 1-Year
|
|
General disorders
Neck Pain
|
0.24%
1/418 • 1-Year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.24%
1/418 • 1-Year
|
|
General disorders
Obstructive Sleep Apnea
|
0.48%
2/418 • 1-Year
|
|
Vascular disorders
Orthostatic Hypotension
|
0.24%
1/418 • 1-Year
|
|
General disorders
Other
|
3.3%
14/418 • 1-Year
|
|
General disorders
Pain
|
1.2%
5/418 • 1-Year
|
|
Cardiac disorders
Palpitations
|
0.48%
2/418 • 1-Year
|
|
Investigations
Peak T Waves
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.24%
1/418 • 1-Year
|
|
General disorders
Post-Nasal Drainage
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Premature Ventricular Contraction
|
0.24%
1/418 • 1-Year
|
|
Reproductive system and breast disorders
Prostatitis
|
0.24%
1/418 • 1-Year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.96%
4/418 • 1-Year
|
|
Vascular disorders
Renal Artery Stenosis
|
0.24%
1/418 • 1-Year
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
0.24%
1/418 • 1-Year
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.24%
1/418 • 1-Year
|
|
Skin and subcutaneous tissue disorders
Skin Bruise
|
0.24%
1/418 • 1-Year
|
|
Skin and subcutaneous tissue disorders
Skin Lesions
|
0.48%
2/418 • 1-Year
|
|
General disorders
Swelling
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Syncope
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Tachycardia
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Thrombus
|
0.24%
1/418 • 1-Year
|
|
General disorders
Tooth Infection
|
0.24%
1/418 • 1-Year
|
|
General disorders
Toothache
|
0.24%
1/418 • 1-Year
|
|
Injury, poisoning and procedural complications
Trauma
|
0.24%
1/418 • 1-Year
|
|
Cardiac disorders
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia
|
0.24%
1/418 • 1-Year
|
|
Renal and urinary disorders
Urinary Tract Infections
|
0.96%
4/418 • 1-Year
|
|
Vascular disorders
VASC Bruise
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
VASC Hematoma
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
VASC Pseudoaneurysm
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
VASC Vessel Stenosis
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Vaso Vagal Response
|
0.24%
1/418 • 1-Year
|
|
Nervous system disorders
Vertigo
|
0.24%
1/418 • 1-Year
|
|
Vascular disorders
Vessel Stenosis
|
0.72%
3/418 • 1-Year
|
|
Gastrointestinal disorders
Viral Gastroenteritis
|
0.24%
1/418 • 1-Year
|
|
Eye disorders
Visual Disturbance
|
0.48%
2/418 • 1-Year
|
|
General disorders
Weakness
|
0.24%
1/418 • 1-Year
|
|
Musculoskeletal and connective tissue disorders
Wrist Sprain
|
0.24%
1/418 • 1-Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Proposals for all publications, abstracts, presentations, or journal manuscripts arising from, or related to the Study will be submitted for approval to the Publications Committee. Accordingly, decisions on timing and content of publications and presentations from the Study will be coordinated with the Study Publication Committee and Sponsor.
- Publication restrictions are in place
Restriction type: OTHER