Trial Outcomes & Findings for Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects (NCT NCT01711983)
NCT ID: NCT01711983
Last Updated: 2020-08-21
Results Overview
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure * Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure 3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
400 participants
Primary outcome timeframe
6 months
Results posted on
2020-08-21
Participant Flow
Participant milestones
| Measure |
Test Device
ASD closure with the GORE® CARDIOFORM Septal Occluder
Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
6-Month Clinical Success Evaluation
STARTED
|
400
|
|
6-Month Clinical Success Evaluation
COMPLETED
|
368
|
|
6-Month Clinical Success Evaluation
NOT COMPLETED
|
32
|
|
6-Month Closure Evaluation
STARTED
|
368
|
|
6-Month Closure Evaluation
COMPLETED
|
342
|
|
6-Month Closure Evaluation
NOT COMPLETED
|
26
|
|
36-Month Closure Evaluation
STARTED
|
342
|
|
36-Month Closure Evaluation
COMPLETED
|
278
|
|
36-Month Closure Evaluation
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Test Device
ASD closure with the GORE® CARDIOFORM Septal Occluder
Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
6-Month Clinical Success Evaluation
Missed Echocardiograph
|
32
|
|
6-Month Closure Evaluation
Technical Failure (No Test Device)
|
26
|
|
36-Month Closure Evaluation
Test Device Removal
|
2
|
|
36-Month Closure Evaluation
Missed Echocardiograph
|
62
|
Baseline Characteristics
Enrolled subjects with non-missing measurement
Baseline characteristics by cohort
| Measure |
Test Device
n=400 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Age, Continuous
|
6.9 years
n=400 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
319 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=400 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
286 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=400 Participants
|
|
Region of Enrollment
United States
|
400 participants
n=400 Participants
|
|
Height
|
122.0 cm
n=400 Participants
|
|
Weight
|
25.0 kg
n=400 Participants
|
|
Hypertension
Current
|
18 Participants
n=400 Participants
|
|
Hypertension
Previous/Never
|
382 Participants
n=400 Participants
|
|
Diabetes Mellitus
Current
|
13 Participants
n=400 Participants
|
|
Diabetes Mellitus
Previous/Never
|
387 Participants
n=400 Participants
|
|
Cigarette Smoking
Current
|
7 Participants
n=400 Participants
|
|
Cigarette Smoking
Previous
|
8 Participants
n=400 Participants
|
|
Cigarette Smoking
Never
|
385 Participants
n=400 Participants
|
|
Headaches
Current
|
15 Participants
n=400 Participants
|
|
Headaches
Previous/Never
|
385 Participants
n=400 Participants
|
|
Migraines
Current
|
15 Participants
n=400 Participants
|
|
Migraines
Previous/Never
|
385 Participants
n=400 Participants
|
|
Cardiac Arrhythmia History
Current
|
13 Participants
n=400 Participants
|
|
Cardiac Arrhythmia History
Previous/Never
|
387 Participants
n=400 Participants
|
|
Stop Flow Balloon Defect Size
|
12.0 mm
n=393 Participants • Enrolled subjects with non-missing measurement
|
|
Multiple Fenestrations
|
94 Participants
n=400 Participants
|
|
Atrial Septal Aneurysm
|
31 Participants
n=400 Participants
|
|
Septal Length
|
34.0 mm
n=396 Participants • Enrolled subjects with non-missing measurement
|
|
Anterior-Superior Aortic Rim Length
|
5.0 mm
n=396 Participants • Enrolled subjects with non-missing measurement
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All enrolled subjects with 6-month clinical success evaluation
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder 2. Safety Success: * Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure * Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure 3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Outcome measures
| Measure |
Test Device
n=368 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With 6-Month Composite Clinical Success
|
332 Participants
|
SECONDARY outcome
Timeframe: During procedure; median duration 68 minutesAmong subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder
Outcome measures
| Measure |
Test Device
n=400 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With Technical Success
|
374 Participants
|
SECONDARY outcome
Timeframe: During procedure; median duration 68 minutesAmong subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.
Outcome measures
| Measure |
Test Device
n=400 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With Procedure Success
|
364 Participants
|
SECONDARY outcome
Timeframe: 30 daysAmong subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure
Outcome measures
| Measure |
Test Device
n=400 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With 30-day SAE
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Enrolled subjects with technical success and 6-month clinical residual defect status evaluation
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
Outcome measures
| Measure |
Test Device
n=342 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With 6-Month Closure Success
|
338 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Enrolled subjects with technical success and 12-month clinical residual defect status evaluation
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.
Outcome measures
| Measure |
Test Device
n=340 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With 12-Month Closure Success
|
337 Participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Enrolled subjects with technical success and 36-month clinical residual defect status evaluation
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.
Outcome measures
| Measure |
Test Device
n=278 Participants
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Number of Subjects With 36-Month Closure Success
|
277 Participants
|
Adverse Events
Test Device
Serious events: 28 serious events
Other events: 260 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Device
n=400 participants at risk
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Angina pectoris
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Atrial thrombosis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Pericardial effusion
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Congenital, familial and genetic disorders
Frenulum breve
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.25%
1/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Medical device site thrombosis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Non-cardiac chest pain
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Immune system disorders
Amyloidosis
|
0.25%
1/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Appendicitis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Cellulitis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Croup infectious
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Ear infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Influenza
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Otitis media
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Respiratory tract infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.25%
1/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Streptococcal sepsis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Subcutaneous abscess
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Viral infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Migraine
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypertrophy
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Surgical and medical procedures
Caesarean section
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
Other adverse events
| Measure |
Test Device
n=400 participants at risk
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Angina pectoris
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Atrial flutter
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Bradycardia
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Cardiac septal hypertrophy
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Dilatation atrial
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Extrasystoles
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Left ventricular dilatation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Mitral valve incompetence
|
1.2%
5/400 • Number of events 5 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Nodal rhythm
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Palpitations
|
4.0%
16/400 • Number of events 17 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Pericardial effusion
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Tachycardia
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Congenital, familial and genetic disorders
Williams syndrome
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Endocrine disorders
Hyperthyroidism
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Endocrine disorders
Thyroid disorder
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Eye swelling
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Ocular hyperaemia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Orbital cyst
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Strabismus
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Vision blurred
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Eye disorders
Vitreous floaters
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
5/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Colitis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
8/400 • Number of events 9 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Dental caries
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
6/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Food poisoning
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Gastritis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.5%
6/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Haematochezia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
12/400 • Number of events 12 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
24/400 • Number of events 26 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Adverse drug reaction
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Asthenia
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Axillary pain
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Cardiac complication associated with device
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Chest discomfort
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Chest pain
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Chills
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Decreased activity
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Exercise tolerance decreased
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Fatigue
|
1.5%
6/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Generalised oedema
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Influenza like illness
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Infusion site extravasation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Nodule
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Non-cardiac chest pain
|
7.8%
31/400 • Number of events 38 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Oedema peripheral
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Pyrexia
|
4.5%
18/400 • Number of events 18 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
General disorders
Swelling
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Immune system disorders
Drug hypersensitivity
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Immune system disorders
Hypersensitivity
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Immune system disorders
Multiple allergies
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Immune system disorders
Seasonal allergy
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Acarodermatitis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Acute sinusitis
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Atypical pneumonia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Bacterial disease carrier
|
0.25%
1/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Bronchitis
|
1.2%
5/400 • Number of events 5 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Candida infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Cellulitis
|
0.75%
3/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Conjunctivitis
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Croup infectious
|
1.2%
5/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Cystitis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Ear infection
|
1.5%
6/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Enterovirus infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Gastroenteritis
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Gastroenteritis viral
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Impetigo
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Influenza
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Lyme disease
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Molluscum contagiosum
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Nasopharyngitis
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Oral candidiasis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Oral viral infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Otitis media
|
3.5%
14/400 • Number of events 14 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Otitis media acute
|
1.5%
6/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Otitis media chronic
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Pharyngitis
|
2.0%
8/400 • Number of events 9 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.8%
7/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Pneumonia
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Respiratory tract infection
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Rhinitis
|
0.50%
2/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Rhinovirus infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Rotavirus infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Sinusitis
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Subcutaneous abscess
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
24/400 • Number of events 27 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Urethritis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Urinary tract infection
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Vaginal infection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Viral infection
|
1.5%
6/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Viral rash
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.8%
7/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Infections and infestations
Vulvovaginitis
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication cardiac
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.25%
1/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
5/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
1.2%
5/400 • Number of events 5 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
3.0%
12/400 • Number of events 12 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
3.0%
12/400 • Number of events 12 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Incision site rash
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.2%
5/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.0%
4/400 • Number of events 5 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Splinter
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Investigations
Cardiac murmur
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Investigations
Chest X-ray abnormal
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Infrapatellar fat pad inflammation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.75%
3/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
6/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Allodynia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Burning sensation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Dizziness
|
1.5%
6/400 • Number of events 6 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Dizziness postural
|
1.2%
5/400 • Number of events 5 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Dysaesthesia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Febrile convulsion
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Headache
|
10.2%
41/400 • Number of events 45 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Hypoaesthesia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Migraine
|
2.5%
10/400 • Number of events 12 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Migraine with aura
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Migraine without aura
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Presyncope
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Syncope
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Tremor
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Nervous system disorders
Vocal cord paresis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Product Issues
Device issue
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Psychiatric disorders
Anxiety
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Psychiatric disorders
Depression
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Psychiatric disorders
Insomnia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Psychiatric disorders
Mental status changes
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Renal and urinary disorders
Dysuria
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Renal and urinary disorders
Haematuria
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Renal and urinary disorders
Proteinuria
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Reproductive system and breast disorders
Breast mass
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Reproductive system and breast disorders
Penile curvature
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
7/400 • Number of events 9 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
7/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
16/400 • Number of events 17 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.0%
4/400 • Number of events 4 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.75%
3/400 • Number of events 3 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Mechanical urticaria
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
7/400 • Number of events 7 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.50%
2/400 • Number of events 2 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Surgical and medical procedures
Knee operation
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Vascular disorders
Air embolism
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Vascular disorders
Angiopathy
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Vascular disorders
Carotidynia
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Vascular disorders
Labile hypertension
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
|
Vascular disorders
Vascular dissection
|
0.25%
1/400 • Number of events 1 • 3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place