Trial Outcomes & Findings for MAPS Trial: Matrix And Platinum Science (NCT NCT00396981)
NCT ID: NCT00396981
Last Updated: 2016-02-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
626 participants
Primary outcome timeframe
12 months
Results posted on
2016-02-17
Participant Flow
Enrollment in the study occurred over 31 months at 26 sites in the US and 17 International. Each site was allowed to enroll up to 60 consecutive subjects; recruitment for the study was competitive. The first subject was enrolled on 29 March 2007 and the enrollment completed on 21 October 2009. A total of 626 subjects were enrolled.
Participant milestones
| Measure |
Matrix 2® Coils for Endovascular Aneurysm Occlusion
Matrix 2® Coils for endovascular aneurysm occlusion
Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil
|
GDC® Coils for Endovascular Aneurysm Occlusion
GDC® Coils for endovascular aneurysm occlusion
GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil
|
|---|---|---|
|
Overall Study
STARTED
|
311
|
315
|
|
Overall Study
COMPLETED
|
296
|
306
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MAPS Trial: Matrix And Platinum Science
Baseline characteristics by cohort
| Measure |
Matrix 2® Coils for Endovascular Aneurysm Occlusion
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil
|
GDC® Coils for Endovascular Aneurysm Occlusion
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
440 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=5 Participants
|
190 participants
n=7 Participants
|
373 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
46 participants
n=5 Participants
|
44 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
China
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: A totoal of 630 subjects were planned for the study. All enrolled MAPS trial subjects' data is included in the ITT anaylsis except for four subjects who were excluded due to the following reasons: one subject did not have an aneurysm and three subjects', a the request of the IRB, due to non GCP compliance in obtaining the inofrmed consent.
Outcome measures
| Measure |
Matrix Coils
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.
|
34 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Reintervention or 12 monthsNumber of participants with angiographic assessment of "complete obliteration".
Outcome measures
| Measure |
Matrix Coils
n=238 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=250 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Angiographic Assessments
|
87 participants
|
89 participants
|
SECONDARY outcome
Timeframe: 12 monthsThe changes in modified Rankin Scores from pre-procedure to 12-month were measured. the outcome below reflects "same or better".
Outcome measures
| Measure |
Matrix Coils
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Neurological Assessments
|
90.1 percentage of participants
|
88.3 percentage of participants
|
SECONDARY outcome
Timeframe: Post-procedureOutcome measures
| Measure |
Matrix Coils
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Technical Procedure Success
|
96.8 percentage of participants
|
97.5 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Matrix Coils
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Target Aneurysm Recurrence
|
42 participants
|
42 participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
Matrix Coils
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Target Aneurysm Recurrence
|
43 participants
|
45 participants
|
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
| Measure |
Matrix Coils
n=311 Participants
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 Participants
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Target Aneurysm Recurrence
|
44 participants
|
46 participants
|
Adverse Events
Matrix Coils
Serious events: 85 serious events
Other events: 112 other events
Deaths: 0 deaths
GDC Coils
Serious events: 80 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Matrix Coils
n=311 participants at risk
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 participants at risk
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Blood and lymphatic system disorders
Total
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Cardiac valve disease
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Cardiovascular disorder
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Total
|
2.3%
7/311 • Number of events 8 • 12 months
|
1.6%
5/315 • Number of events 5 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Total
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Vision blurred
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Eye disorders
Total
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Total
|
0.96%
3/311 • Number of events 3 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
General disorders
Catheter site discharge
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
General disorders
Catheter site haematoma
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
General disorders
Catheter site haemorrhage
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Death
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Multi-organ failure
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Total
|
2.6%
8/311 • Number of events 8 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Hepatobiliary disorders
Total
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Immune system disorders
Total
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Central nervous system infection
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Clostridial infection
|
0.32%
1/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Herpes zoster
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Infections and infestations
Pneumonia escherichia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Staphylococcal infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Wound infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Total
|
3.5%
11/311 • Number of events 14 • 12 months
|
1.6%
5/315 • Number of events 5 • 12 months
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Injury, poisoning and procedural complications
Total
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Investigations
Sputum culture positive
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Investigations
Total
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Metabolism and nutrition disorders
Total
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Total
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign cardiac neoplasm
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Total
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Brain oedema
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid arterial embolus
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Carotid artery dissection
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Cerebral artery embolism
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Nervous system disorders
Cerebral artery thrombosis
|
2.9%
9/311 • Number of events 9 • 12 months
|
2.5%
8/315 • Number of events 8 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Diplegia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Embolic stroke
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Nervous system disorders
Encephalopathy
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Nervous system disorders
Headache
|
0.64%
2/311 • Number of events 2 • 12 months
|
1.9%
6/315 • Number of events 6 • 12 months
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Hydrocephalus
|
0.96%
3/311 • Number of events 3 • 12 months
|
1.9%
6/315 • Number of events 6 • 12 months
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Intracranial pressure increased
|
0.32%
1/311 • Number of events 1 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Ischaemic stroke
|
5.1%
16/311 • Number of events 16 • 12 months
|
4.4%
14/315 • Number of events 15 • 12 months
|
|
Nervous system disorders
Lethargy
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Loss of consciousness
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Neurological symptom
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Paralysis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
2.6%
8/311 • Number of events 8 • 12 months
|
2.9%
9/315 • Number of events 9 • 12 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
4/311 • Number of events 4 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Nervous system disorders
Total
|
16.7%
52/311 • Number of events 64 • 12 months
|
16.8%
53/315 • Number of events 69 • 12 months
|
|
Psychiatric disorders
Confusional state
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Psychiatric disorders
Total
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Total
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Reproductive system and breast disorders
Total
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cryptogenic organising pneumonia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Total
|
1.9%
6/311 • Number of events 8 • 12 months
|
1.9%
6/315 • Number of events 6 • 12 months
|
|
Vascular disorders
Artery dissection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Femoral artery aneurysm
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Vasospasm
|
5.8%
18/311 • Number of events 19 • 12 months
|
6.3%
20/315 • Number of events 29 • 12 months
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Vessel perforation
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Total
|
7.7%
24/311 • Number of events 27 • 12 months
|
7.6%
24/315 • Number of events 34 • 12 months
|
Other adverse events
| Measure |
Matrix Coils
n=311 participants at risk
Matrix 2® Coils for endovascular aneurysm occlusion
|
GDC Coils
n=315 participants at risk
GDC® Coils for endovascular aneurysm occlusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Total
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Cardiac disorders
Total
|
2.3%
7/311 • Number of events 8 • 12 months
|
2.2%
7/315 • Number of events 7 • 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Ear and labyrinth disorders
Total
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Endocrine disorders
Total
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Diplopia
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Eye pain
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Eye disorders
Eye swelling
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Eye disorders
Macular degeneration
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Photophobia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Eye disorders
Photopsia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Retinal haemorrhage
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Eye disorders
Strabismus
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Eye disorders
Vision blurred
|
0.96%
3/311 • Number of events 3 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Eye disorders
Visual disturbance
|
0.32%
1/311 • Number of events 1 • 12 months
|
1.6%
5/315 • Number of events 5 • 12 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Eye disorders
Total
|
3.2%
10/311 • Number of events 13 • 12 months
|
4.8%
15/315 • Number of events 16 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
3.2%
10/311 • Number of events 10 • 12 months
|
3.2%
10/315 • Number of events 10 • 12 months
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
4/311 • Number of events 4 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Total
|
4.5%
14/311 • Number of events 20 • 12 months
|
4.1%
13/315 • Number of events 16 • 12 months
|
|
General disorders
Adverse drug reaction
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Asthenia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
General disorders
Catheter site discharge
|
1.9%
6/311 • Number of events 6 • 12 months
|
3.2%
10/315 • Number of events 10 • 12 months
|
|
General disorders
Catheter site haematoma
|
3.9%
12/311 • Number of events 12 • 12 months
|
5.1%
16/315 • Number of events 16 • 12 months
|
|
General disorders
Catheter site haemorrhage
|
1.3%
4/311 • Number of events 4 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
General disorders
Catheter site pain
|
2.6%
8/311 • Number of events 8 • 12 months
|
1.9%
6/315 • Number of events 6 • 12 months
|
|
General disorders
Catheter site rash
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Chest pain
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
General disorders
Fatigue
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Hyperthermia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Infusion site extravasation
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Oedema peripheral
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Peripheral coldness
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
General disorders
Pyrexia
|
1.3%
4/311 • Number of events 4 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
General disorders
Total
|
10.6%
33/311 • Number of events 43 • 12 months
|
9.8%
31/315 • Number of events 40 • 12 months
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Immune system disorders
Total
|
0.00%
0/311 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Infections and infestations
Bacteraemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Ear infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Hepatitis E
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Infusion site infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Lung infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Infections and infestations
Meningitis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Oral candidiasis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.6%
5/311 • Number of events 5 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Tracheitis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection bact
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
2.6%
8/311 • Number of events 9 • 12 months
|
2.9%
9/315 • Number of events 9 • 12 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Infections and infestations
Total
|
6.8%
21/311 • Number of events 25 • 12 months
|
4.8%
15/315 • Number of events 18 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.32%
1/311 • Number of events 1 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Injury, poisoning and procedural complications
Total
|
1.6%
5/311 • Number of events 5 • 12 months
|
3.2%
10/315 • Number of events 10 • 12 months
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Investigations
Troponin increased
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Investigations
Ultrasound Doppler abnormal
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Investigations
Urine sodium increased
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Investigations
Total
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
4/311 • Number of events 4 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Metabolism and nutrition disorders
Total
|
2.3%
7/311 • Number of events 12 • 12 months
|
2.2%
7/315 • Number of events 13 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/311 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Total
|
1.6%
5/311 • Number of events 6 • 12 months
|
4.1%
13/315 • Number of events 14 • 12 months
|
|
Nervous system disorders
Balance disorder
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
CNS ventriculitis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid artery dissection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebral artery embolism
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Cerebral artery thrombosis
|
2.3%
7/311 • Number of events 7 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Nervous system disorders
Convulsion
|
0.00%
0/311 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Headache
|
17.4%
54/311 • Number of events 59 • 12 months
|
18.1%
57/315 • Number of events 68 • 12 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/311 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Nervous system disorders
Intracranial aneurysm
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.95%
3/315 • Number of events 3 • 12 months
|
|
Nervous system disorders
Lethargy
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Migraine
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Syncope
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.64%
2/311 • Number of events 2 • 12 months
|
1.3%
4/315 • Number of events 5 • 12 months
|
|
Nervous system disorders
Tremor
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Nervous system disorders
Total
|
23.5%
73/311 • Number of events 89 • 12 months
|
24.8%
78/315 • Number of events 100 • 12 months
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Confusional state
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Delirium
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Psychiatric disorders
Depression
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Psychiatric disorders
Insomnia
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.00%
0/315 • 12 months
|
|
Psychiatric disorders
Mental status changes
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Total
|
2.3%
7/311 • Number of events 7 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/311 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Total
|
0.00%
0/311 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.64%
2/311 • Number of events 2 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
5/311 • Number of events 5 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Total
|
2.6%
8/311 • Number of events 8 • 12 months
|
2.2%
7/315 • Number of events 8 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
4/311 • Number of events 4 • 12 months
|
1.3%
4/315 • Number of events 4 • 12 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/311 • 12 months
|
0.63%
2/315 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Skin and subcutaneous tissue disorders
Total
|
1.9%
6/311 • Number of events 6 • 12 months
|
2.9%
9/315 • Number of events 9 • 12 months
|
|
Vascular disorders
Artery dissection
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/311 • 12 months
|
0.32%
1/315 • Number of events 1 • 12 months
|
|
Vascular disorders
Hot flush
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Hypertension
|
0.96%
3/311 • Number of events 3 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Hypotension
|
1.9%
6/311 • Number of events 6 • 12 months
|
2.2%
7/315 • Number of events 7 • 12 months
|
|
Vascular disorders
Intermittent claudication
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Phlebitis
|
0.32%
1/311 • Number of events 1 • 12 months
|
0.00%
0/315 • 12 months
|
|
Vascular disorders
Vasospasm
|
2.9%
9/311 • Number of events 9 • 12 months
|
2.5%
8/315 • Number of events 8 • 12 months
|
|
Vascular disorders
Total
|
7.4%
23/311 • Number of events 23 • 12 months
|
5.4%
17/315 • Number of events 17 • 12 months
|
Additional Information
S. Claiboren Johnston, MD, PhD
University of California, UCSF Medical Center
Phone: 415-502-7487
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60