Trial Outcomes & Findings for GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients (NCT NCT00738894)
NCT ID: NCT00738894
Last Updated: 2020-11-20
Results Overview
A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
664 participants
Primary outcome timeframe
24 months
Results posted on
2020-11-20
Participant Flow
Participant milestones
| Measure |
Device Closure
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Overall Study
STARTED
|
441
|
223
|
|
Overall Study
COMPLETED
|
402
|
190
|
|
Overall Study
NOT COMPLETED
|
39
|
33
|
Reasons for withdrawal
| Measure |
Device Closure
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
13
|
|
Overall Study
Withdrawal by Subject
|
10
|
15
|
|
Overall Study
Physician Decision
|
4
|
5
|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
Baseline characteristics by cohort
| Measure |
Device Closure
n=441 Participants
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
n=223 Participants
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Total
n=664 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 9.3 • n=441 Participants
|
44.8 years
STANDARD_DEVIATION 9.6 • n=223 Participants
|
45.2 years
STANDARD_DEVIATION 9.4 • n=664 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=441 Participants
|
85 Participants
n=223 Participants
|
265 Participants
n=664 Participants
|
|
Sex: Female, Male
Male
|
261 Participants
n=441 Participants
|
138 Participants
n=223 Participants
|
399 Participants
n=664 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=441 Participants
|
9 Participants
n=223 Participants
|
31 Participants
n=664 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
413 Participants
n=441 Participants
|
213 Participants
n=223 Participants
|
626 Participants
n=664 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=441 Participants
|
1 Participants
n=223 Participants
|
7 Participants
n=664 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=441 Participants
|
0 Participants
n=223 Participants
|
2 Participants
n=664 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=441 Participants
|
2 Participants
n=223 Participants
|
2 Participants
n=664 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=441 Participants
|
0 Participants
n=223 Participants
|
0 Participants
n=664 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=441 Participants
|
12 Participants
n=223 Participants
|
26 Participants
n=664 Participants
|
|
Race (NIH/OMB)
White
|
412 Participants
n=441 Participants
|
203 Participants
n=223 Participants
|
615 Participants
n=664 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=441 Participants
|
1 Participants
n=223 Participants
|
4 Participants
n=664 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=441 Participants
|
5 Participants
n=223 Participants
|
15 Participants
n=664 Participants
|
|
Region of Enrollment
United States
|
216 Participants
n=441 Participants
|
115 Participants
n=223 Participants
|
331 Participants
n=664 Participants
|
|
Region of Enrollment
Canada
|
17 Participants
n=441 Participants
|
8 Participants
n=223 Participants
|
25 Participants
n=664 Participants
|
|
Region of Enrollment
Denmark
|
79 Participants
n=441 Participants
|
38 Participants
n=223 Participants
|
117 Participants
n=664 Participants
|
|
Region of Enrollment
Finland
|
18 Participants
n=441 Participants
|
8 Participants
n=223 Participants
|
26 Participants
n=664 Participants
|
|
Region of Enrollment
Norway
|
25 Participants
n=441 Participants
|
14 Participants
n=223 Participants
|
39 Participants
n=664 Participants
|
|
Region of Enrollment
Sweden
|
64 Participants
n=441 Participants
|
31 Participants
n=223 Participants
|
95 Participants
n=664 Participants
|
|
Region of Enrollment
United Kingdom
|
22 Participants
n=441 Participants
|
9 Participants
n=223 Participants
|
31 Participants
n=664 Participants
|
|
Time from qualifying event to randomization
|
100 days
STANDARD_DEVIATION 52 • n=441 Participants
|
101 days
STANDARD_DEVIATION 53 • n=223 Participants
|
101 days
STANDARD_DEVIATION 53 • n=664 Participants
|
|
Current smoking
|
63 Participants
n=441 Participants
|
25 Participants
n=223 Participants
|
88 Participants
n=664 Participants
|
|
Hypertension
|
112 Participants
n=441 Participants
|
58 Participants
n=223 Participants
|
170 Participants
n=664 Participants
|
|
Diabetes mellitus
|
18 Participants
n=441 Participants
|
10 Participants
n=223 Participants
|
28 Participants
n=664 Participants
|
|
Stroke or TIA before index event
Previous either
|
62 Participants
n=441 Participants
|
23 Participants
n=223 Participants
|
85 Participants
n=664 Participants
|
|
Stroke or TIA before index event
Previous stroke
|
42 Participants
n=441 Participants
|
13 Participants
n=223 Participants
|
55 Participants
n=664 Participants
|
|
Stroke or TIA before index event
Previous TIA
|
26 Participants
n=441 Participants
|
11 Participants
n=223 Participants
|
37 Participants
n=664 Participants
|
|
Index event
Stroke w/ symptoms >=24 hr
|
402 Participants
n=441 Participants
|
199 Participants
n=223 Participants
|
601 Participants
n=664 Participants
|
|
Index event
Stroke symptoms <24 hr, w/ imaging confirmation
|
39 Participants
n=441 Participants
|
24 Participants
n=223 Participants
|
63 Participants
n=664 Participants
|
|
Patent foramen ovale shunt size
Small (1-5 bubbles)
|
77 Participants
n=425 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
43 Participants
n=216 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
120 Participants
n=641 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
|
Patent foramen ovale shunt size
Moderate (6-25 bubbles)
|
166 Participants
n=425 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
94 Participants
n=216 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
260 Participants
n=641 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
|
Patent foramen ovale shunt size
Large (>25 bubbles)
|
182 Participants
n=425 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
79 Participants
n=216 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
261 Participants
n=641 Participants • 16 device closure subjects and 7 medical management subjects reported shunt assessment of unknown, unable to perform, or not performed.
|
|
Atrial septal aneurysm
|
86 Participants
n=422 Participants • Atrial septal aneurysm was determined during the PFO closure procedure; it was not recorded for any medical management subjects, nor for 19 of the 28 device closure subjects with no study device implant attempt.
|
—
|
86 Participants
n=422 Participants • Atrial septal aneurysm was determined during the PFO closure procedure; it was not recorded for any medical management subjects, nor for 19 of the 28 device closure subjects with no study device implant attempt.
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intention to Treat: includes all subjects randomized
A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.
Outcome measures
| Measure |
Device Closure
n=441 Participants
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
n=223 Participants
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)
|
6 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Intention to Treat: includes all subjects randomized and evaluated for brain infarct
Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days. An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm.
Outcome measures
| Measure |
Device Closure
n=383 Participants
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
n=177 Participants
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Intention to Treat: all subjects randomized
Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site
Outcome measures
| Measure |
Device Closure
n=441 Participants
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
n=223 Participants
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Number of Subjects With Study-related Serious Adverse Events
|
102 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All subjects randomized to test (device) arm with 24-month PFO closure assessment
Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up. Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles).
Outcome measures
| Measure |
Device Closure
n=318 Participants
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Number of Subjects With Effective Closure in Test (Device) Arm
|
312 Participants
|
—
|
Adverse Events
Device Closure
Serious events: 102 serious events
Other events: 324 other events
Deaths: 2 deaths
Medical Management
Serious events: 62 serious events
Other events: 154 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device Closure
n=441 participants at risk
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
n=223 participants at risk
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Nervous system disorders
Headache
|
1.4%
6/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.91%
4/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.91%
4/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Nervous system disorders
Dizziness
|
0.91%
4/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Dysaesthesia
|
1.4%
6/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Migraine with aura
|
1.1%
5/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Nervous system disorders
Syncope
|
0.45%
2/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Paraesthesia
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Migraine
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Carotid artery dissection
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Dysarthria
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Hemiparesis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Monoparesis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Aphasia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Dural arteriovenous fistula
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Partial seizures
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Sciatica
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Tension headache
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Thunderclap headache
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Ulnar tunnel syndrome
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Vertebral artery dissection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
10/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Palpitations
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Bradycardia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Cardiac arrest
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Cardiac tamponade
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Pericardial cyst
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Pulseless electrical activity
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Face injury
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Appendicitis
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Pneumonia
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Infections and infestations
Campylobacter infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Cystitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Empyema
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Influenza
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Malaria
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Renal abscess
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Staphylococcal skin infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Vascular disorders
Hypotension
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Aortic dissection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Arteriovenous fistula
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Haematoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Hypertension
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Vena cava thrombosis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Fatigue
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Adverse drug reaction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Chest discomfort
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Chest pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Complication of device removal
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Puncture site haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Depression
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Anxiety
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Psychiatric disorders
Bipolar disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Completed suicide
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Delusion
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Major depression
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Mania
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Paranoia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Hepatobiliary disorders
Biliary colic
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.91%
4/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Eye haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Glaucoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Retinal detachment
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Vision blurred
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Product Issues
Device dislocation
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Product Issues
Thrombosis in device
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Endocrine disorders
Adrenal mass
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Surgical and medical procedures
Osteosynthesis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
Other adverse events
| Measure |
Device Closure
n=441 participants at risk
PFO closure with study septal occluder device plus antiplatelet medical therapy
Septal Occluder Device: GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
Medical Management
n=223 participants at risk
Antiplatelet medical therapy alone
Antiplatelet Medical Therapy: Investigator's choice of one of three regimen options specified in protocol
|
|---|---|---|
|
Infections and infestations
Erysipelas
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Headache
|
8.4%
37/441 • 24 months
|
14.3%
32/223 • 24 months
|
|
Nervous system disorders
Dizziness
|
7.7%
34/441 • 24 months
|
7.2%
16/223 • 24 months
|
|
Nervous system disorders
Dysaesthesia
|
4.3%
19/441 • 24 months
|
8.5%
19/223 • 24 months
|
|
Nervous system disorders
Migraine
|
3.4%
15/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Nervous system disorders
Migraine with aura
|
1.8%
8/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
6/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Nervous system disorders
Paraesthesia
|
2.3%
10/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
1/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Syncope
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Memory impairment
|
1.1%
5/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Dysarthria
|
0.68%
3/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Monoparesis
|
0.68%
3/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Presyncope
|
1.6%
7/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Aphasia
|
0.23%
1/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Nervous system disorders
Hemiparesis
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Seizure
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Balance disorder
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Cervical radiculopathy
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Facial paralysis
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Visual field defect
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Amnesia
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Ataxia
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Disturbance in attention
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Nervous system disorders
Sensory disturbance
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Tension headache
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Nerve compression
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Sensory loss
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Tremor
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Amimia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Aura
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Clumsiness
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Diabetic neuropathy
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Dizziness postural
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Encephalopathy
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Exertional headache
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Facial paresis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Head discomfort
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Loss of consciousness
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Morton's neuralgia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Occipital neuralgia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Parkinson's disease
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Pineal gland cyst
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Quadrantanopia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Speech disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Nervous system disorders
Subdural effusion
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Ulnar neuritis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Nervous system disorders
Upper motor neurone lesion
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
23/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Infections and infestations
Sinusitis
|
2.9%
13/441 • 24 months
|
2.7%
6/223 • 24 months
|
|
Infections and infestations
Bronchitis
|
2.5%
11/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
2.7%
12/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Infections and infestations
Influenza
|
2.5%
11/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
8/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Infections and infestations
Pneumonia
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Infections and infestations
Acute sinusitis
|
0.68%
3/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Infections and infestations
Pharyngitis
|
0.91%
4/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Herpes zoster
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Skin infection
|
0.23%
1/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Infections and infestations
Chronic tonsillitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Cystitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Ear infection
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Onychomycosis
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Otitis media
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Cellulitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Epididymitis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Folliculitis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Otitis externa
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Otitis media acute
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Pyelonephritis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Subcutaneous abscess
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Tinea pedis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Tooth infection
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Vaginal infection
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Viral labyrinthitis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Abscess limb
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Atypical pneumonia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Conjunctivitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Groin infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Hordeolum
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Impetigo
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Localised infection
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Oral viral infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Paronychia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Perichondritis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Pilonidal cyst
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Rash pustular
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Tinea cruris
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Tonsillitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Infections and infestations
Viral infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Infections and infestations
Wound infection
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Palpitations
|
14.5%
64/441 • 24 months
|
6.3%
14/223 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
21/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Tachycardia
|
2.3%
10/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Angina pectoris
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Extrasystoles
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Arrhythmia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Cardiac discomfort
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Cardiac disorders
Sinus node dysfunction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
19/441 • 24 months
|
4.0%
9/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
18/441 • 24 months
|
3.6%
8/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
18/441 • 24 months
|
2.7%
6/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
9/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.68%
3/441 • 24 months
|
2.7%
6/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.91%
4/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
5/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.1%
5/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myokymia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
11/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
2.0%
9/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
1.1%
5/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
6/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.4%
6/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.91%
4/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
1.1%
5/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
1.1%
5/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.91%
4/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.91%
4/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Exposure to body fluid
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Face injury
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Persistent corneal epithelial defect
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
5.2%
23/441 • 24 months
|
4.9%
11/223 • 24 months
|
|
General disorders
Fatigue
|
2.9%
13/441 • 24 months
|
4.0%
9/223 • 24 months
|
|
General disorders
Chest discomfort
|
2.5%
11/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
General disorders
Oedema peripheral
|
2.3%
10/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Chest pain
|
0.91%
4/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
General disorders
Peripheral swelling
|
0.68%
3/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
General disorders
Adverse drug reaction
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Pyrexia
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Influenza like illness
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Oedema
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Puncture site haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Drug withdrawal syndrome
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Feeling abnormal
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Feeling hot
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Gait disturbance
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Hernia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Malaise
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Puncture site pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Suprapubic pain
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Temperature intolerance
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Thirst
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
General disorders
Vessel puncture site bruise
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
General disorders
Vessel puncture site haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
3.2%
14/441 • 24 months
|
3.1%
7/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.91%
4/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
6/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.91%
4/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.68%
3/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Abdominal wall cyst
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Gastrointestinal disorders
Toothache
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Anxiety
|
3.9%
17/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Psychiatric disorders
Depression
|
1.8%
8/441 • 24 months
|
3.6%
8/223 • 24 months
|
|
Psychiatric disorders
Insomnia
|
1.8%
8/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Psychiatric disorders
Post stroke depression
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Psychiatric disorders
Affect lability
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Confusional state
|
0.68%
3/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Panic attack
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Bipolar disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Major depression
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Agitated depression
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Alcohol abuse
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Drug abuse
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Executive dysfunction
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Hallucination
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Mood altered
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Paranoia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Psychiatric disorders
Stress
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
13/441 • 24 months
|
2.7%
6/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
7/441 • 24 months
|
2.2%
5/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
7/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.91%
4/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus mucosal hypertrophy
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Hypertension
|
4.8%
21/441 • 24 months
|
4.0%
9/223 • 24 months
|
|
Vascular disorders
Hypotension
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Haematoma
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Flushing
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Varicose vein
|
0.68%
3/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Essential hypertension
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Hot flush
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Infarction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Intermittent claudication
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Phlebitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Visual impairment
|
1.8%
8/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Eye disorders
Vision blurred
|
0.91%
4/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Eye disorders
Diplopia
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Eye disorders
Blindness transient
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Cataract
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Eye haemorrhage
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Mydriasis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Photopsia
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Blepharospasm
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Blindness
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Dry eye
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Eye pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Iridocyclitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Iritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Keratitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Lens disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Ocular discomfort
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Ocular hyperaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Eye disorders
Scleritis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.68%
3/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
5/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
2/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Postprandial hypoglycaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.1%
5/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.23%
1/441 • 24 months
|
1.3%
3/223 • 24 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Premenstrual dysphoric disorder
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Testicular mass
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Reproductive system and breast disorders
Testicular pain
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.8%
8/441 • 24 months
|
1.8%
4/223 • 24 months
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
6/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.91%
4/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Cupulolithiasis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
6/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Renal and urinary disorders
Dysuria
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Haematuria
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Renal and urinary disorders
Urine abnormality
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.91%
4/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Endocrine disorders
Thyroid mass
|
0.23%
1/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Investigations
Weight decreased
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Investigations
Weight increased
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Investigations
Blood magnesium decreased
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Investigations
Grip strength decreased
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Investigations
Heart rate irregular
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Investigations
Platelet count increased
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Investigations
Prostatic specific antigen abnormal
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.45%
2/441 • 24 months
|
0.90%
2/223 • 24 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.45%
2/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Immune system disorders
Seasonal allergy
|
0.23%
1/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Surgical and medical procedures
Dental disorder prophylaxis
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/441 • 24 months
|
0.45%
1/223 • 24 months
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Congenital, familial and genetic disorders
Pulmonary arteriovenous fistula
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.23%
1/441 • 24 months
|
0.00%
0/223 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of results requires review and approval by REDUCE Publication and Presentation Committee
- Publication restrictions are in place
Restriction type: OTHER