Trial Outcomes & Findings for PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (NCT NCT02675114)
NCT ID: NCT02675114
Last Updated: 2026-01-14
Results Overview
Number of patients that had any of these events
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
1000 participants
Primary outcome timeframe
1 year
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
Surgical Aortic Valve Replacement (SAVR)
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
Overall Study
STARTED
|
497
|
503
|
|
Overall Study
As Treated
|
454
|
496
|
|
Overall Study
Valve Implant
|
453
|
495
|
|
Overall Study
COMPLETED
|
424
|
490
|
|
Overall Study
NOT COMPLETED
|
73
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
Baseline characteristics by cohort
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
Total
n=950 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 6.08 • n=14 Participants
|
73.3 years
STANDARD_DEVIATION 5.83 • n=10 Participants
|
73.4 years
STANDARD_DEVIATION 5.95 • n=24 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=14 Participants
|
161 Participants
n=10 Participants
|
292 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
323 Participants
n=14 Participants
|
335 Participants
n=10 Participants
|
658 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=14 Participants
|
15 Participants
n=10 Participants
|
27 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=14 Participants
|
7 Participants
n=10 Participants
|
16 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
4 Participants
n=14 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
409 Participants
n=14 Participants
|
458 Participants
n=10 Participants
|
867 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
6 Participants
n=14 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: As Treated
Number of patients that had any of these events
Outcome measures
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
|
68 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: As Treated. Patients who had atrial fibrillation prior to the procedure were excluded from the analysis.
Number of patients with this event
Outcome measures
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=369 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=417 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
New Onset Atrial Fibrillation
|
145 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Discharge (expected average of 7 days)Population: As Treated
Number of days from index procedure to discharge
Outcome measures
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
Length of Index Hospitalization
|
7.4 Days
Standard Deviation 3.48
|
2.9 Days
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 30 daysPopulation: As Treated
Number of patients that had any of these events
Outcome measures
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=435 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=492 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points
|
133 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: As Treated
Number of patients that died or had a stroke
Outcome measures
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
Death or Stroke
|
15 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: As Treated
Number of patients that had a stroke
Outcome measures
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 Participants
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 Participants
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
All Stroke
|
11 Participants
|
3 Participants
|
Adverse Events
Surgical Aortic Valve Replacement (SAVR)
Serious events: 221 serious events
Other events: 305 other events
Deaths: 11 deaths
Transcatheter Aortic Valve Replacement (TAVR)
Serious events: 153 serious events
Other events: 133 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 participants at risk
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 participants at risk
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
Infections and infestations
Escherichia urinary tract infection
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.1%
5/454 • Number of events 5 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Postoperative wound infection
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Respiratory tract infection
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Infections and infestations
Septic shock
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Serratia sepsis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Vascular access site infection
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/454 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
2.9%
13/454 • Number of events 14 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Investigations
Blood pressure systolic increased
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Investigations
Cardiac murmur
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Investigations
International normalised ratio increased
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Investigations
Pulmonary arterial pressure increased
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Investigations
Troponin increased
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Investigations
White blood cell count increased
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.44%
2/454 • Number of events 3 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Gout
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/454 • 1 year
|
1.0%
5/496 • Number of events 5 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/454 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Ataxia
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral infarction
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
1.5%
7/454 • Number of events 7 • 1 year
|
0.81%
4/496 • Number of events 4 • 1 year
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Nerve compression
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Nervous system disorders
Sciatica
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Nervous system disorders
Syncope
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Product Issues
Device breakage
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Product Issues
Lead dislodgement
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Psychiatric disorders
Depression
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Psychiatric disorders
Hallucination, visual
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
7/454 • Number of events 7 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.22%
1/454 • Number of events 3 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Renal injury
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Renal mass
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Scrotal haematocoele
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
5/454 • Number of events 5 • 1 year
|
0.60%
3/496 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haemorrhage
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
18/454 • Number of events 20 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
7/454 • Number of events 7 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
6/454 • Number of events 6 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Surgical and medical procedures
Appendicectomy
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Knee operation
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Pericardial excision
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Surgical and medical procedures
Stent placement
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial haemorrhage
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/454 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Vascular disorders
Femoral artery perforation
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Vascular disorders
Haematoma
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Vascular disorders
Hypertension
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Vascular disorders
Hypotension
|
1.3%
6/454 • Number of events 6 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/454 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Vascular disorders
Renovascular hypertension
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Vascular disorders
Temporal arteritis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Vascular disorders
Vessel perforation
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Chest pain
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
General disorders
Complication associated with device
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Death
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
General disorders
Gait disturbance
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Localised oedema
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Mass
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
General disorders
Oedema peripheral
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Pyrexia
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Sudden cardiac death
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Systemic inflammatory response syndrome
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Hepatobiliary disorders
Bile duct stone
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
1/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/454 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Infections and infestations
Biliary sepsis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.00%
0/454 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Infections and infestations
Cholecystitis infective
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Infections and infestations
Endocarditis
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
5/454 • Number of events 5 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
2.0%
9/454 • Number of events 9 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
5/454 • Number of events 5 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute left ventricular failure
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.81%
4/496 • Number of events 4 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
9.3%
42/454 • Number of events 43 • 1 year
|
2.2%
11/496 • Number of events 12 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
2.6%
12/454 • Number of events 13 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrial tachycardia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
3.3%
15/454 • Number of events 15 • 1 year
|
4.4%
22/496 • Number of events 23 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bundle branch block left
|
0.22%
1/454 • Number of events 1 • 1 year
|
2.4%
12/496 • Number of events 12 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
5/454 • Number of events 6 • 1 year
|
0.81%
4/496 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.88%
4/454 • Number of events 4 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
7/454 • Number of events 7 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiogenic shock
|
1.3%
6/454 • Number of events 6 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiomyopathy
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Diastolic dysfunction
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Dressler's syndrome
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Left ventricular enlargement
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Nodal arrhythmia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Paravalvular aortic regurgitation
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.81%
4/496 • Number of events 4 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
6/454 • Number of events 6 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Cardiac disorders
Pericardial haemorrhage
|
1.8%
8/454 • Number of events 8 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Pericarditis constrictive
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Prosthetic cardiac valve thrombosis
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Cardiac disorders
Pulseless electrical activity
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus node dysfunction
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Systolic anterior motion of mitral valve
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
1.1%
5/454 • Number of events 5 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.60%
3/496 • Number of events 3 • 1 year
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Endocrine disorders
Thyroid disorder
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Eye disorders
Cataract
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Eye disorders
Retinal detachment
|
0.00%
0/454 • 1 year
|
0.40%
2/496 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.44%
2/454 • Number of events 2 • 1 year
|
2.0%
10/496 • Number of events 11 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.22%
1/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oroantral fistula
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
2/454 • Number of events 2 • 1 year
|
0.00%
0/496 • 1 year
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/454 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.22%
1/454 • Number of events 1 • 1 year
|
0.00%
0/496 • 1 year
|
|
General disorders
Asthenia
|
0.66%
3/454 • Number of events 3 • 1 year
|
0.20%
1/496 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Surgical Aortic Valve Replacement (SAVR)
n=454 participants at risk
SAVR with a commercially available bioprosthetic valve.
|
Transcatheter Aortic Valve Replacement (TAVR)
n=496 participants at risk
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
13.0%
59/454 • Number of events 60 • 1 year
|
0.00%
0/496 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
24/454 • Number of events 24 • 1 year
|
0.00%
0/496 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
31.9%
145/454 • Number of events 154 • 1 year
|
7.3%
36/496 • Number of events 38 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
5.7%
26/454 • Number of events 26 • 1 year
|
5.2%
26/496 • Number of events 26 • 1 year
|
|
Cardiac disorders
Bundle branch block left
|
8.1%
37/454 • Number of events 37 • 1 year
|
18.5%
92/496 • Number of events 93 • 1 year
|
|
Cardiac disorders
Bundle branch block right
|
6.2%
28/454 • Number of events 28 • 1 year
|
0.00%
0/496 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
19.4%
88/454 • Number of events 89 • 1 year
|
0.00%
0/496 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
8.8%
40/454 • Number of events 41 • 1 year
|
0.00%
0/496 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.6%
39/454 • Number of events 40 • 1 year
|
0.00%
0/496 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
28/454 • Number of events 29 • 1 year
|
0.00%
0/496 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place