Trial Outcomes & Findings for MitraClip EXPAND G4 Study (NCT NCT04177394)
NCT ID: NCT04177394
Last Updated: 2025-07-11
Results Overview
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
1164 participants
Primary outcome timeframe
At 30 days
Results posted on
2025-07-11
Participant Flow
Participant milestones
| Measure |
MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Overall Study
STARTED
|
1164
|
|
Overall Study
COMPLETED
|
1053
|
|
Overall Study
NOT COMPLETED
|
111
|
Reasons for withdrawal
| Measure |
MitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Overall Study
Death
|
16
|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Missed visits
|
61
|
|
Overall Study
Expected Visits
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MitraClip G4 System
n=1164 Participants
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Age, Continuous
|
77.5 years
STANDARD_DEVIATION 9.1 • n=1164 Participants
|
|
Sex: Female, Male
Female
|
514 Participants
n=1164 Participants
|
|
Sex: Female, Male
Male
|
650 Participants
n=1164 Participants
|
|
Region of Enrollment
Saudi Arabia
|
3 participants
n=1164 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=1164 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=1164 Participants
|
|
Region of Enrollment
United States
|
586 participants
n=1164 Participants
|
|
Region of Enrollment
Japan
|
95 participants
n=1164 Participants
|
|
Region of Enrollment
Italy
|
144 participants
n=1164 Participants
|
|
Region of Enrollment
Israel
|
10 participants
n=1164 Participants
|
|
Region of Enrollment
France
|
52 participants
n=1164 Participants
|
|
Region of Enrollment
Germany
|
232 participants
n=1164 Participants
|
|
Region of Enrollment
Spain
|
22 participants
n=1164 Participants
|
|
Height
|
167.78 cm
STANDARD_DEVIATION 11.26 • n=1163 Participants • All available data has been reported.
|
|
Weight
|
73.25 Kg
STANDARD_DEVIATION 18.91 • n=1164 Participants
|
|
Body Mass Index
|
25.91 kg/m^2
STANDARD_DEVIATION 5.89 • n=1163 Participants • All available data has been reported
|
|
Euro Score II
|
6.48 points on a scale
STANDARD_DEVIATION 6.85 • n=472 Participants • All available data has been reported
|
|
STS Replacement Score
|
7.55 percentage
STANDARD_DEVIATION 6.21 • n=608 Participants • All available data has been reported
|
|
Prior Cardiac Sugeries
|
266 Participants
n=1164 Participants
|
|
Prior Coronary Revascularization
|
448 Participants
n=1164 Participants
|
|
Coronary Artery Bypass Graft (CABG)
|
176 Participants
n=1164 Participants
|
|
Prior Cardiac Interventions (PCI)
|
364 Participants
n=1164 Participants
|
|
Permanent Pacemaker
|
315 Participants
n=1164 Participants
|
|
Prior Heart Failure Hospitalization within 1 year
|
472 Participants
n=1164 Participants
|
PRIMARY outcome
Timeframe: At 30 daysPopulation: All available data has been reported
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Outcome measures
| Measure |
MitraClip G4 System
n=983 Participants
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
0+:None
|
350 Participants
|
|
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
1+: Mild
|
547 Participants
|
|
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
2+: Moderate
|
65 Participants
|
|
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
3+: Moderate to Severe
|
17 Participants
|
|
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
4+: Severe
|
4 Participants
|
PRIMARY outcome
Timeframe: At 30 daysPopulation: All available data has been reported
MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications.
Outcome measures
| Measure |
MitraClip G4 System
n=1159 Participants
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Occurrence of Major Adverse Events (MAE) at 30 Days
All Cause Death
|
16 Participants
|
|
Occurrence of Major Adverse Events (MAE) at 30 Days
Myocardial Infarction
|
2 Participants
|
|
Occurrence of Major Adverse Events (MAE) at 30 Days
Stroke
|
6 Participants
|
|
Occurrence of Major Adverse Events (MAE) at 30 Days
Non-elective CV Surgery for device related complications
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 DaysPopulation: All available data has been reported.
Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure
Outcome measures
| Measure |
MitraClip G4 System
n=1159 Participants
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Number of Participants With APS
|
1119 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 DaysPopulation: All available data has been reported.
Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge.
Outcome measures
| Measure |
MitraClip G4 System
n=1164 Participants
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Number of Participants With ADS
|
1118 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 daysIn-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed.
Outcome measures
| Measure |
MitraClip G4 System
n=1164 Participants
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Occurrence of In-hospital Major Adverse Events (MAE)
All Cause Death
|
9 Participants
|
|
Occurrence of In-hospital Major Adverse Events (MAE)
Myocardial Infarction
|
0 Participants
|
|
Occurrence of In-hospital Major Adverse Events (MAE)
Stroke
|
3 Participants
|
|
Occurrence of In-hospital Major Adverse Events (MAE)
Non-elective CV surgery for device related complications
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 5 yearsAll Cause Mortality Through 5 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 5 yearsHeart Failure Hospitalization through 5 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 5 yearsOccurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 5 yearsDevice Related Complications as defined in the protocol through 5 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 yearMR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 yearMR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 yearsDifference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 1, 2, 3, 4 and 5 yearDifference Between QOL at 30 days, 1, 2, 3, 4 and 5 year
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days, 1, 2, 3, 4 and 5 yearDifference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year
Outcome measures
Outcome data not reported
Adverse Events
MitraClip G4 System
Serious events: 209 serious events
Other events: 0 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
MitraClip G4 System
n=1164 participants at risk
Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.34%
4/1164 • Number of events 4 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Blood and lymphatic system disorders
ANAEMIA OF CHRONIC DISEASE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
ARRHYTHMIA
|
1.4%
16/1164 • Number of events 16 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.4%
16/1164 • Number of events 16 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
ATRIAL SEPTAL DEFECT ACQUIRED
|
0.69%
8/1164 • Number of events 8 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
CARDIAC FAILURE
|
3.2%
37/1164 • Number of events 37 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.4%
16/1164 • Number of events 18 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
CARDIAC PERFORATION
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.17%
2/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
1.2%
14/1164 • Number of events 14 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
MITRAL PERFORATION
|
0.77%
9/1164 • Number of events 9 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
1.2%
14/1164 • Number of events 15 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
MITRAL VALVE STENOSIS
|
0.26%
3/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.26%
3/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Gastrointestinal disorders
ASTHENIA
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
General disorders
CARDIAC COMPLICATION ASSOCIATED WITH DEVICE
|
0.26%
3/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
General disorders
CHEST PAIN
|
0.26%
3/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
General disorders
DEATH
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
General disorders
DEVICE CAPTURING ISSUE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Infections and infestations
CARDIAC INFECTION
|
0.26%
3/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Infections and infestations
INFECTION
|
1.7%
20/1164 • Number of events 21 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
0.77%
9/1164 • Number of events 9 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Injury, poisoning and procedural complications
VASCULAR PROCEDURE COMPLICATION
|
0.26%
3/1164 • Number of events 3 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Investigations
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Investigations
MEAN ARTERIAL PRESSURE DECREASED
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Investigations
METABOLISM AND NUTRITION DISORDERS
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Investigations
HYPERKALAEMIA
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Investigations
METABOLIC ACIDOSIS
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
CONVULSION
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.43%
5/1164 • Number of events 5 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
SIMPLE PARTIAL SEIZURES
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
SOMNOLENCE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
SYNCOPE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Nervous system disorders
UNRESPONSIVE TO STIMULI
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Psychiatric disorders
DELIRIUM
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.5%
18/1164 • Number of events 18 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.34%
4/1164 • Number of events 4 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.43%
5/1164 • Number of events 5 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.34%
4/1164 • Number of events 4 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Vascular disorders
ARTERIAL OCCLUSIVE DISEASE
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Vascular disorders
EMBOLISM
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Vascular disorders
HAEMORRHAGE
|
3.4%
39/1164 • Number of events 42 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Vascular disorders
HYPERTENSION
|
0.17%
2/1164 • Number of events 2 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Vascular disorders
HYPOTENSION
|
0.95%
11/1164 • Number of events 11 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.09%
1/1164 • Number of events 1 • All-Cause Mortality and Adverse Events are reported through 30 days.
Rates are reported as number of patients with an event out of the total number of patients in the study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place