Study: NCT03733392

Adverse event: ARRHYTHMIA NEW
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 334 at risk

Adverse event: ARRHYTHMIA PRE-EXISTING
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia Pre-Existing indicates reportable events in which a subject's arrhythmia occurred in severity, frequency, or other manner that was significantly worse than their baseline condition.
Frequency: 4 affected / 334 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 334 at risk

Adverse event: BLEEDING/ANEMIA
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 334 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: CEREBROVASCULAR ACCIDENT/ STROKE
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 334 at risk

Adverse event: CHEST PAIN/ANGINA (CARDIAC)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: CORONARY ARTERY THROMBOSIS/OCCLUSION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: EMBOLIC EVENT
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 334 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 334 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 334 at risk

Adverse event: INCOMPLETE AV, SINUS NODE, OR OTHER HEART BLOCK
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 334 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: PAIN (NON-CARDIAC)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 334 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 334 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 334 at risk

Adverse event: Pulmonary vein stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 334 at risk

Adverse event: VASCULAR ACCESS COMPLICATIONS
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 334 at risk

Adverse event: VASCULAR BLEEDING/LOCAL HEMATOMAS/ECCHYMOSIS
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 334 at risk

Adverse event: ARM WEAKNESS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 334 at risk

Adverse event: PREAUTOMATIC PAUSE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: Chronotropic incompetence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 334 at risk

Adverse event: CARDIAC PERFORATION OR TAMPONADE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: Arteriovenous fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 334 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 334 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 334 at risk

Adverse event: SHORT TERM LAPSES IN MEMORY
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 334 at risk

Adverse event: PAIN (NON-CARDIAC)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 334 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 334 at risk

Adverse event: SKIN BURNS/DERMATITIS/ERYTHEMA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 334 at risk

Adverse event: VASCULAR ACCESS COMPLICATIONS
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 334 at risk

Adverse event: PAIN (NON-CARDIAC)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 334 at risk

Adverse event: ARRHYTHMIA NEW
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: ARRHYTHMIA PRE-EXISTING
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmia Pre-Existing indicates reportable events in which a subject's arrhythmia occurred in severity, frequency, or other manner that was significantly worse than their baseline condition.
Frequency: 1 affected / 38 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: RESPIRATORY COMPROMISE/DECOMPENSATION
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: THROMBOSIS/THROMBUS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: INCOMPLETE AV, SINUS NODE, OR OTHER HEART BLOCK
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: CARDIAC PERFORATION OR TAMPONADE
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 38 at risk