Trial Outcomes & Findings for Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System (NCT NCT05120193)
NCT ID: NCT05120193
Last Updated: 2025-04-23
Results Overview
The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: * Death * Myocardial infarction * Phrenic nerve paralysis * Transient ischemic attack (TIA) * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Major vascular access complications / bleeding * Heart block * Gastroparesis * Severe pericarditis * Hospitalization due to cardiovascular or pulmonary AE Within 30 days: • Cardiac tamponade / perforation Within 90 days: • Atrio-esophageal fistula Within 180 days: • Pulmonary vein stenosis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
477 participants
Primary outcome timeframe
180 Days
Results posted on
2025-04-23
Participant Flow
There were 37 Roll-In subjects, 8 subjects that exited the study prior to randomization, and 12 randomized subjects that exited the study prior to the index ablation procedure.
Participant milestones
| Measure |
Sphere-9 Catheter
Sphere-9™ Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
208
|
|
Overall Study
COMPLETED
|
209
|
199
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
Baseline characteristics by cohort
| Measure |
Sphere-9 Catheter
n=212 Participants
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=208 Participants
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
151 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
206 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
199 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
177 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 DaysPopulation: Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.
The primary safety endpoint is the incidence of the following device- or procedure-related serious adverse events (SAEs) following the index ablation procedure: Within 7 days: * Death * Myocardial infarction * Phrenic nerve paralysis * Transient ischemic attack (TIA) * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Major vascular access complications / bleeding * Heart block * Gastroparesis * Severe pericarditis * Hospitalization due to cardiovascular or pulmonary AE Within 30 days: • Cardiac tamponade / perforation Within 90 days: • Atrio-esophageal fistula Within 180 days: • Pulmonary vein stenosis
Outcome measures
| Measure |
Sphere-9 Catheter
n=212 Participants
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=208 Participants
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Percent of Subjects With a Primary Adverse Event
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through 12-month follow-up and excluding a 90-day blanking period. The following are considered primary effectiveness endpoint failures: * Inability to isolate all targeted pulmonary veins during the index procedure. * Ablation using devices other than the assigned study device for any left atrial ablation during the index procedure. * Any repeat ablation, surgical ablation, or arrhythmia surgery for treatment of recurrent AF/AT/AFL after the index procedure. * Documented AF/AT/AFL recurrence after the 90-day blanking period. * Class I or III AAD dose increase from the historic maximum ineffective dose (prior to the index procedure) or initiation of a new Class I or III AAD for treatment of AF/AT/AFL after the 90-day blanking period. * DC cardioversion for AF/AT/AFL after the 90-day blanking period.
Outcome measures
| Measure |
Sphere-9 Catheter
n=210 Participants
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=202 Participants
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Percent of Subjects Free From Primary Effectiveness Failure
|
155 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.
Total energy application time during the index ablation procedure
Outcome measures
| Measure |
Sphere-9 Catheter
n=212 Participants
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=206 Participants
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Energy Application Time
|
7.1 minutes
Standard Deviation 2.0
|
36.4 minutes
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Day 0Population: Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.
Time from start to end of energy delivery
Outcome measures
| Measure |
Sphere-9 Catheter
n=212 Participants
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=208 Participants
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Treatment Time
|
46.7 minutes
Standard Deviation 20.0
|
73.5 minutes
Standard Deviation 34.4
|
SECONDARY outcome
Timeframe: Day 0Population: Subjects who provided informed consent, were randomized and underwent insertion of the assigned study device (experimental or active comparator), defined as the device emerging from the sheath into the bloodstream.
Time from start to end of venous access
Outcome measures
| Measure |
Sphere-9 Catheter
n=212 Participants
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=208 Participants
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Procedure Time
|
100.9 minutes
Standard Deviation 30.8
|
126.1 minutes
Standard Deviation 49.2
|
Adverse Events
Sphere-9 Catheter
Serious events: 36 serious events
Other events: 0 other events
Deaths: 2 deaths
THERMOCOOL SMARTTOUCH SF
Serious events: 41 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Sphere-9 Catheter
n=212 participants at risk
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
THERMOCOOL SMARTTOUCH SF
n=208 participants at risk
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Mapping and Ablation: Minimally invasive catheter mapping and ablation procedure
|
|---|---|---|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Cystitis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/212 • Up to 12 months
|
0.96%
2/208 • Number of events 2 • Up to 12 months
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
3/212 • Number of events 3 • Up to 12 months
|
2.4%
5/208 • Number of events 6 • Up to 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.94%
2/212 • Number of events 2 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Bradycardia
|
1.4%
3/212 • Number of events 3 • Up to 12 months
|
1.4%
3/208 • Number of events 3 • Up to 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Cardiac disorders
Cardiac Failure
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.96%
2/208 • Number of events 2 • Up to 12 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
4/212 • Number of events 4 • Up to 12 months
|
0.96%
2/208 • Number of events 2 • Up to 12 months
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
4/212 • Number of events 4 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Coronary artery stenosis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Pericardial effusion
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Cardiac disorders
Pericarditis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/212 • Up to 12 months
|
1.4%
3/208 • Number of events 3 • Up to 12 months
|
|
Endocrine disorders
Thyroid disorder
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Eye disorders
Retinal tear
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Mesenteric vascular insufficiency
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Oesophageal mucosa erythema
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
General disorders
Gait disturbance
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
General disorders
Impaired healing
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Infections and infestations
Bacterial infection
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/212 • Up to 12 months
|
0.96%
2/208 • Number of events 2 • Up to 12 months
|
|
Infections and infestations
Cellulitis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Infections and infestations
Pneumonia
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Infections and infestations
Sepsis
|
0.94%
2/212 • Number of events 2 • Up to 12 months
|
0.96%
2/208 • Number of events 3 • Up to 12 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Systemic infection
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Mouth Injury
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Investigations
Troponin increased
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/212 • Up to 12 months
|
0.96%
2/208 • Number of events 2 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.94%
2/212 • Number of events 2 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Syncope
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Vocal cord paralysis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Renal and urinary disorders
Benign prostatic hyperplasia
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Renal and urinary disorders
Prostatomegaly
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Immune system disorders
Respiratory failure
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Surgical and medical procedures
Medical device implantation
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/212 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Aortic aneurysm
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.48%
1/208 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Aortic stenosis
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
|
Vascular disorders
Hypertensive urgency
|
0.47%
1/212 • Number of events 1 • Up to 12 months
|
0.00%
0/208 • Up to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60