Trial Outcomes & Findings for Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study (NCT NCT00650936)
NCT ID: NCT00650936
Last Updated: 2019-07-09
Results Overview
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1000 participants
Primary outcome timeframe
24 months
Results posted on
2019-07-09
Participant Flow
Participant milestones
| Measure |
AMPLATZER Septal Occluder
The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
|
|---|---|
|
Overall Study
STARTED
|
1000
|
|
Overall Study
COMPLETED
|
930
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Baseline characteristics by cohort
| Measure |
AMPLATZER Septal Occluder
n=1000 Participants
The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
|
|---|---|
|
Age, Continuous
|
21 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
649 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
351 Participants
n=5 Participants
|
|
Height
|
135.3 centimeters
n=5 Participants
|
|
Weight
|
45 kilograms
n=5 Participants
|
|
Qp/Qs
|
2.1 ratio
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The analysis population for the primary efficacy endpoint was all subjects who either reached their two-year visit or had a device-related hemodynamic compromise event.
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Outcome measures
| Measure |
AMPLATZER Septal Occluder
n=928 Participants
The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
|
|---|---|
|
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
|
0.65 percentage of participants
Interval to 1.4
One-sided analysis conducted and reported in the final report
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The analysis population for the co-primary effectiveness endpoint was all subjects who either reached their two-year visit or demonstrated closure of the atrial septal defect prior to or at their 2-year visit.
The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt \< 2mm) without the need for surgical repair
Outcome measures
| Measure |
AMPLATZER Septal Occluder
n=987 Participants
The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
|
|---|---|
|
Co-Primary Effectiveness Endpoint
|
97.87 percentage of participants
Interval 96.8 to 98.7
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The analysis population for the co-primary safety endpoint is all subjects who either reached their two-year visit or had a device or delivery system related adverse event prior to their 2-year visit.
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Outcome measures
| Measure |
AMPLATZER Septal Occluder
n=930 Participants
The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
|
|---|---|
|
Co-Primary Safety Endpoint
|
6.34 percentage of participants
Interval 4.86 to 8.11
|
Adverse Events
AMPLATZER Septal Occluder
Serious events: 57 serious events
Other events: 489 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMPLATZER Septal Occluder
n=1000 participants at risk
Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
AMPLATZER Septal Occluder: AMPLATZER Septal Occluder
|
|---|---|
|
General disorders
Abnormal Lab Value
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Acute Life Threatening Event
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Acute Subdural Hematoma
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Air Embolus
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Anemias
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Aortic Aneurysms
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Arteriovenous (AV) Fistula
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Atrial Fibrillation
|
0.60%
6/1000 • Number of events 6
|
|
General disorders
Atrial Flutter
|
0.30%
3/1000 • Number of events 3
|
|
General disorders
Bleeding
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Breath Holding Spell
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Cancer
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Cardiac Arrest
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Cardiac Erosion
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Chest Pain
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Congestive Heart Failure
|
0.30%
3/1000 • Number of events 3
|
|
General disorders
Device Embolization
|
0.40%
4/1000 • Number of events 4
|
|
General disorders
Diabetes Mellitus
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Elective Procedure
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Elective Surgery
|
0.30%
3/1000 • Number of events 3
|
|
General disorders
Fever
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Gastroenteritis
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Headache
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Hematuria
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Hypotension
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Hypoxemia
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Migraine
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Numbness
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Palpitations
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Pericardial Effusion
|
0.40%
4/1000 • Number of events 4
|
|
General disorders
Pericarditis
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Pleural Effusion
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Pneumonia
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Presyncope
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
ST Segment Changes
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
SVC Syndrome
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Sepsis
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Stridor
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Stroke
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Surgical Closure of ASD
|
0.70%
7/1000 • Number of events 7
|
|
General disorders
Syncope
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Tingling
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
VASC Pseudoaneurysm
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Vaso Vagal Response
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Visual Disturbance
|
0.10%
1/1000 • Number of events 1
|
Other adverse events
| Measure |
AMPLATZER Septal Occluder
n=1000 participants at risk
Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).
AMPLATZER Septal Occluder: AMPLATZER Septal Occluder
|
|---|---|
|
Cardiac disorders
AV Block
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Abdominal Pain
|
1.0%
10/1000 • Number of events 11
|
|
Blood and lymphatic system disorders
Abdominal Coagulation Parameter
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Abdominal Lab Value
|
0.20%
2/1000 • Number of events 3
|
|
Cardiac disorders
Accelerated Idioventricular Rhythm
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Accelerated Junctional Rhythm
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Acrocyanosis
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
0.10%
1/1000 • Number of events 1
|
|
Ear and labyrinth disorders
Acute Otitis Media
|
0.20%
2/1000 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Edema
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Allergic Drug Reaction
|
0.10%
1/1000 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anesthesia Reaction
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Angina Pectoris
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Antidromic Reciprocating Tachycardia
|
0.10%
1/1000 • Number of events 1
|
|
Gastrointestinal disorders
Antral Erosion
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Aortic Root Dilation
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Aortic Valve Regurgitation and Insufficiency/Valvular Regurgitation Aortic Valve
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
Arterial Hypertension/Hypertension
|
0.50%
5/1000 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
3/1000 • Number of events 3
|
|
Injury, poisoning and procedural complications
Atelectasis
|
1.5%
15/1000 • Number of events 15
|
|
Cardiac disorders
Atrial Ectopic Beats and Rhythm / Premature Atrial Beats and Contractions
|
2.2%
22/1000 • Number of events 24
|
|
Cardiac disorders
Atrial Escape Beat
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
11/1000 • Number of events 12
|
|
Cardiac disorders
Atrial Flutter
|
0.70%
7/1000 • Number of events 7
|
|
Cardiac disorders
Atrial Tachycardia
|
0.60%
6/1000 • Number of events 6
|
|
General disorders
Aura
|
0.40%
4/1000 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.40%
4/1000 • Number of events 4
|
|
Infections and infestations
Bacteremia
|
0.10%
1/1000 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Bacterial Infection of the Skin
|
0.20%
2/1000 • Number of events 2
|
|
Psychiatric disorders
Behavioral Alterations
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Biventricular Hypertrophy / Combined Ventricular Hypertrophy
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Bleeding
|
1.9%
19/1000 • Number of events 20
|
|
Eye disorders
Blurred Vision
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Borderline Prolongation of QT Interval
|
0.10%
1/1000 • Number of events 1
|
|
Injury, poisoning and procedural complications
Brachial Plexus Injury
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Broad QRS Complex Arrhythmias
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.30%
3/1000 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruise/Purpura Simplex
|
5.9%
59/1000 • Number of events 62
|
|
Cardiac disorders
Cardiomegaly
|
0.20%
2/1000 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
8.6%
86/1000 • Number of events 96
|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
0.40%
4/1000 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
2/1000 • Number of events 3
|
|
Renal and urinary disorders
Chronic Renal Failure
|
0.10%
1/1000 • Number of events 1
|
|
Infections and infestations
Common Cold / Upper Respiratory Tract Infection
|
0.80%
8/1000 • Number of events 8
|
|
Cardiac disorders
Congestive Heart Failure
|
0.20%
2/1000 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.30%
3/1000 • Number of events 3
|
|
Vascular disorders
Coronary Artery Anomaly
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
Coronary Artery Disease
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Cough
|
0.40%
4/1000 • Number of events 4
|
|
General disorders
Decreased Appetite
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Decreased Exercise Tolerance
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Dehydration
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Dental Trauma
|
0.10%
1/1000 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.10%
1/1000 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Embolization
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Diarrhea
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty Catching Breath
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
Dilated Main Pulmonary Artery (MPA)
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Discomfort
|
0.10%
1/1000 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Dizziness
|
1.7%
17/1000 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Drug Rash
|
0.20%
2/1000 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
16/1000 • Number of events 18
|
|
Cardiac disorders
EKG Abnormalities
|
0.10%
1/1000 • Number of events 2
|
|
Cardiac disorders
Echo Finding
|
0.40%
4/1000 • Number of events 4
|
|
General disorders
Edema
|
0.50%
5/1000 • Number of events 5
|
|
Surgical and medical procedures
Elective Surgery
|
0.30%
3/1000 • Number of events 3
|
|
Gastrointestinal disorders
Emesis / Vomiting
|
2.5%
25/1000 • Number of events 25
|
|
Cardiac disorders
Enlarged or Dilated Left Atrium (LA)
|
0.10%
1/1000 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Epistaxis
|
1.8%
18/1000 • Number of events 19
|
|
General disorders
Fainting / Blackout
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Fatigue / General Fatigue
|
0.60%
6/1000 • Number of events 6
|
|
General disorders
Febrile Seizures
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Fever
|
1.1%
11/1000 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
First Degree Heart / AV Block / Cardiac Arrhythmia / First Degree AV Block
|
1.0%
10/1000 • Number of events 10
|
|
General disorders
Foreign Bodies
|
0.10%
1/1000 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.20%
2/1000 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.30%
3/1000 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal Illness
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
General Malaise
|
0.10%
1/1000 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Head and Neck Abscesses
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Headache
|
5.5%
55/1000 • Number of events 56
|
|
Cardiac disorders
Heart Block
|
0.30%
3/1000 • Number of events 3
|
|
Cardiac disorders
Heart Failure
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Heart Murmur
|
0.10%
1/1000 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
0.20%
2/1000 • Number of events 2
|
|
Gastrointestinal disorders
Hematochezia
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Hematoma
|
2.7%
27/1000 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.10%
1/1000 • Number of events 1
|
|
Infections and infestations
Herpes Simplex
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Hyperlipidemia
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
1.0%
10/1000 • Number of events 10
|
|
General disorders
Hypothermia
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Incomplete Right Bundle Branch Block
|
1.7%
17/1000 • Number of events 17
|
|
Cardiac disorders
Increased Left Atrial Pressure
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Increased PR Interval
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Interventricular Conduction Delay
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Inverted T Wave
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Irregular Menstrual Period
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Irritability
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Junctional Escape Rhythm / Intermittent Junctional Rhythm
|
0.60%
6/1000 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Lacerations
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Left Axis Deviation
|
0.30%
3/1000 • Number of events 3
|
|
Cardiac disorders
Left Ventricular Hypertrophy (by EKG)
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Left Ventricular Hypertrophy (by Echo)
|
0.40%
4/1000 • Number of events 4
|
|
General disorders
Lightheadedness
|
0.40%
4/1000 • Number of events 4
|
|
Cardiac disorders
Long Q-T
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Low Back Pain
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Low/ Coronary Atrial Rhythm
|
0.70%
7/1000 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Lower Left Lobe Infiltrate
|
0.10%
1/1000 • Number of events 1
|
|
Eye disorders
Macular Degeneration
|
0.10%
1/1000 • Number of events 1
|
|
Gastrointestinal disorders
Melena
|
0.20%
2/1000 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Mid-Sternal Chest Pressure
|
0.30%
3/1000 • Number of events 3
|
|
General disorders
Migraine
|
2.7%
27/1000 • Number of events 29
|
|
Cardiac disorders
Mitral Valve Prolapse
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Mitral Valve Regurgitation / Mitral Insufficiency
|
0.70%
7/1000 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Multiple Calcified Granulomata in the Lung Fields
|
0.10%
1/1000 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.50%
5/1000 • Number of events 6
|
|
General disorders
Nausea
|
1.2%
12/1000 • Number of events 12
|
|
General disorders
Nickel Allergy
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Non-Cardiac Chest Pain
|
0.50%
5/1000 • Number of events 6
|
|
Cardiac disorders
Non-Specific EKG Change
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Numbness
|
0.60%
6/1000 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Sleep Apnea
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Orthostatic Hypertension
|
0.40%
4/1000 • Number of events 4
|
|
Ear and labyrinth disorders
Otitis Media
|
0.20%
2/1000 • Number of events 2
|
|
General disorders
Overhydration
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Pain
|
1.4%
14/1000 • Number of events 14
|
|
Cardiac disorders
Palpitations
|
5.0%
50/1000 • Number of events 53
|
|
Psychiatric disorders
Panic Attack
|
0.10%
1/1000 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Paroxysmal Atrial Fibrillation
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Paroxysmal Atrial Tachycardia
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Paroxysmal Supraventricular Tachycardia
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Pericardial Effusion
|
2.7%
27/1000 • Number of events 27
|
|
Cardiac disorders
Pericarditis
|
0.20%
2/1000 • Number of events 2
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.60%
6/1000 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.40%
4/1000 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
3/1000 • Number of events 4
|
|
Cardiac disorders
Premature Ventricular Contraction
|
0.80%
8/1000 • Number of events 8
|
|
Cardiac disorders
Presyncope
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.40%
4/1000 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.30%
3/1000 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Nodule
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Venous Congestion
|
0.10%
1/1000 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
3/1000 • Number of events 3
|
|
Cardiac disorders
Regular Narrow QRS Tachycardia / Supraventricular Tachycardias
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Residual Interatrial Communication
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Residual Shunt
|
0.10%
1/1000 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Right Atrial Enlargement
|
0.30%
3/1000 • Number of events 3
|
|
Cardiac disorders
Right Axis Deviation
|
0.70%
7/1000 • Number of events 7
|
|
Cardiac disorders
Right Bundle Branch Block / Complete Right Bundle Branch Block
|
0.30%
3/1000 • Number of events 3
|
|
Cardiac disorders
Right Ventricular Conduction Delay
|
0.40%
4/1000 • Number of events 4
|
|
Cardiac disorders
Right Ventricular Hypertrophy
|
0.40%
4/1000 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Tear
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
ST Segment Changes
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
ST-T-Wave Abnormality
|
0.30%
3/1000 • Number of events 3
|
|
Nervous system disorders
Seizure / Convulsions Epilepsy
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Sinus Arrhythmias
|
0.70%
7/1000 • Number of events 7
|
|
Cardiac disorders
Sinus Bradycardia / Sinus Bradycardia (Cardiac Arrhythmia)
|
2.3%
23/1000 • Number of events 23
|
|
Cardiac disorders
Sinus Tachycardia
|
1.5%
15/1000 • Number of events 15
|
|
General disorders
Sinusitis
|
0.20%
2/1000 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin Lesions
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Snoring
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Sore Throat
|
0.40%
4/1000 • Number of events 4
|
|
General disorders
Strep Throat
|
0.20%
2/1000 • Number of events 2
|
|
Vascular disorders
Stroke
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Swelling
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Syncope
|
0.30%
3/1000 • Number of events 3
|
|
Cardiac disorders
T-Wave Abnormalities
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
T-Wave Inversion
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.20%
2/1000 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.10%
1/1000 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.10%
1/1000 • Number of events 1
|
|
Cardiac disorders
Thrombus
|
0.10%
1/1000 • Number of events 1
|
|
Nervous system disorders
Tingling
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
Transient Ischemic Attack
|
0.10%
1/1000 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve
|
0.20%
2/1000 • Number of events 2
|
|
Cardiac disorders
Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia
|
0.20%
2/1000 • Number of events 2
|
|
Renal and urinary disorders
Ureteral Dysfunction
|
0.10%
1/1000 • Number of events 1
|
|
Renal and urinary disorders
Urinary Calculi
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
VASC Bleeding
|
0.20%
2/1000 • Number of events 2
|
|
Vascular disorders
VASC Bruise
|
0.10%
1/1000 • Number of events 1
|
|
Vascular disorders
VASC Hematoma
|
0.50%
5/1000 • Number of events 5
|
|
Vascular disorders
VASC Pain
|
0.50%
5/1000 • Number of events 5
|
|
Vascular disorders
VASC Pseudoaneurysm
|
0.20%
2/1000 • Number of events 2
|
|
Nervous system disorders
Vaso Vagal Response
|
0.30%
3/1000 • Number of events 3
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
5/1000 • Number of events 5
|
|
Infections and infestations
Viral Syndrome
|
0.10%
1/1000 • Number of events 1
|
|
General disorders
Other
|
0.20%
2/1000 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place