MAPS Trial: Matrix And Platinum Science

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00396981
First received: November 6, 2006
Last updated: March 17, 2014
Last verified: February 2013
Results First Received: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intracranial Aneurysms
Interventions: Device: Matrix 2® coils for endovascular aneurysm occlusion
Device: GDC® coils for endovascular aneurysm occlusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Matrix 2® Coils for Endovascular Aneurysm Occlusion     GDC® Coils for Endovascular Aneurysm Occlusion  
STARTED     311     315  
COMPLETED     296     306  
NOT COMPLETED     15     9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Matrix 2® Coils for Endovascular Aneurysm Occlusion     GDC® Coils for Endovascular Aneurysm Occlusion     Total  
Number of Participants  
[units: participants]
  311     315     626  
Age  
[units: years]
Mean ± Standard Deviation
  55.7  ± 11.6     54.4  ± 13.2     55.0  ± 12.5  
Gender  
[units: participants]
     
Female     229     211     440  
Male     82     104     186  
Region of Enrollment  
[units: participants]
     
France     17     15     32  
United States     183     190     373  
Mexico     1     2     3  
Canada     16     15     31  
Spain     46     44     90  
Turkey     4     6     10  
Australia     1     3     4  
Norway     6     5     11  
Germany     13     10     23  
China     7     9     16  
United Kingdom     17     16     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Target Aneurysm Recurrence (TAR) Defined as Clinically Relevant Recurrence Resulting in Target Aneurysm Reintervention, Rupture/Re-rupture and/or Death From an Unknown Cause.   [ Time Frame: 12 months ]

2.  Secondary:   Angiographic Assessments   [ Time Frame: Reintervention or 12 months ]

3.  Secondary:   Neurological Assessments   [ Time Frame: 12 months ]

4.  Secondary:   Technical Procedure Success   [ Time Frame: Post-procedure ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
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


Other Adverse Events
    Matrix 2® Coils for Endovascular Aneurysm Occlusion     GDC® Coils for Endovascular Aneurysm Occlusion  
Total, other (not including serious) adverse events      
# participants affected / at risk     112/311     120/315  
Blood and lymphatic system disorders      
Anaemia      
# participants affected / at risk     3/311 (0.96%)     2/315 (0.63%)  
# events     3     2  
Leukocytosis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     3/311 (0.96%)     3/315 (0.95%)  
# events     3     3  
Cardiac disorders      
Angina pectoris      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Arrhythmia supraventricular      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Atrial fibrillation      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Bradycardia      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Cardiac failure congestive      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Sinus tachycardia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Supraventricular tachycardia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Tachycardia      
# participants affected / at risk     3/311 (0.96%)     2/315 (0.63%)  
# events     3     2  
Total      
# participants affected / at risk     7/311 (2.25%)     7/315 (2.22%)  
# events     8     7  
Ear and labyrinth disorders      
Ear pain      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Tinnitus      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Vertigo      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     2/311 (0.64%)     1/315 (0.32%)  
# events     2     1  
Endocrine disorders      
Diabetes insipidus      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Eye disorders      
Blindness unilateral      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Diplopia      
# participants affected / at risk     3/311 (0.96%)     1/315 (0.32%)  
# events     3     1  
Eye pain      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Eye swelling      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Macular degeneration      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Photophobia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Photopsia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Retinal artery occlusion      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Retinal haemorrhage      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Strabismus      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Vision blurred      
# participants affected / at risk     3/311 (0.96%)     4/315 (1.27%)  
# events     3     4  
Visual disturbance      
# participants affected / at risk     1/311 (0.32%)     5/315 (1.59%)  
# events     1     5  
Vitreous floaters      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     10/311 (3.22%)     15/315 (4.76%)  
# events     13     16  
Gastrointestinal disorders      
Abdominal pain      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Abdominal pain upper      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Constipation      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Diarrhoea      
# participants affected / at risk     3/311 (0.96%)     0/315 (0.00%)  
# events     3     0  
Gastritis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Hernial eventration      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Nausea      
# participants affected / at risk     10/311 (3.22%)     10/315 (3.17%)  
# events     10     10  
Tongue disorder      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Vomiting      
# participants affected / at risk     4/311 (1.29%)     3/315 (0.95%)  
# events     4     3  
Total      
# participants affected / at risk     14/311 (4.50%)     13/315 (4.13%)  
# events     20     16  
General disorders      
Adverse drug reaction      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Asthenia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Catheter site discharge      
# participants affected / at risk     6/311 (1.93%)     10/315 (3.17%)  
# events     6     10  
Catheter site haematoma      
# participants affected / at risk     12/311 (3.86%)     16/315 (5.08%)  
# events     12     16  
Catheter site haemorrhage      
# participants affected / at risk     4/311 (1.29%)     3/315 (0.95%)  
# events     4     3  
Catheter site pain      
# participants affected / at risk     8/311 (2.57%)     6/315 (1.90%)  
# events     8     6  
Catheter site rash      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Chest pain      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Fatigue      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Hyperthermia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Infusion site extravasation      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Oedema peripheral      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Peripheral coldness      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Pyrexia      
# participants affected / at risk     4/311 (1.29%)     2/315 (0.63%)  
# events     4     2  
Total      
# participants affected / at risk     33/311 (10.61%)     31/315 (9.84%)  
# events     43     40  
Immune system disorders      
Contrast media allergy      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Drug hypersensitivity      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hypersensitivity      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     3/315 (0.95%)  
# events     0     3  
Infections and infestations      
Bacteraemia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Catheter site infection      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Clostridium difficile colitis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Ear infection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Hepatitis E      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Infusion site infection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Lung infection      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Meningitis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Nasopharyngitis      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Oral candidiasis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Pneumonia      
# participants affected / at risk     5/311 (1.61%)     1/315 (0.32%)  
# events     5     1  
Respiratory tract infection      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Tracheitis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Upper respiratory tract infection      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Upper respiratory tract infection bact      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Urinary tract infection      
# participants affected / at risk     8/311 (2.57%)     9/315 (2.86%)  
# events     9     9  
Viral infection      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     21/311 (6.75%)     15/315 (4.76%)  
# events     25     18  
Injury, poisoning and procedural complications      
Ankle fracture      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Contusion      
# participants affected / at risk     2/311 (0.64%)     1/315 (0.32%)  
# events     2     1  
Patella fracture      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Procedural hypertension      
# participants affected / at risk     1/311 (0.32%)     4/315 (1.27%)  
# events     1     4  
Procedural hypotension      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Procedural nausea      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Radiation skin injury      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Scratch      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Skeletal injury      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     5/311 (1.61%)     10/315 (3.17%)  
# events     5     10  
Investigations      
Electrocardiogram ST segment abnormal      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Troponin increased      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Ultrasound Doppler abnormal      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Urine sodium increased      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     1/311 (0.32%)     3/315 (0.95%)  
# events     1     3  
Metabolism and nutrition disorders      
Dehydration      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Electrolyte imbalance      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Fluid overload      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hyperchloraemia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Hyperglycaemia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hyperkalaemia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Hypermagnesaemia      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Hypocalcaemia      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Hypokalaemia      
# participants affected / at risk     1/311 (0.32%)     2/315 (0.63%)  
# events     1     2  
Hyponatraemia      
# participants affected / at risk     4/311 (1.29%)     2/315 (0.63%)  
# events     4     2  
Hypophosphataemia      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Metabolic disorder      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     7/311 (2.25%)     7/315 (2.22%)  
# events     12     13  
Musculoskeletal and connective tissue disorders      
Arthralgia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Back pain      
# participants affected / at risk     3/311 (0.96%)     3/315 (0.95%)  
# events     3     3  
Fibromyalgia      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Muscle spasms      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Muscle twitching      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Musculoskeletal pain      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Musculoskeletal stiffness      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Neck pain      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Osteoporotic fracture      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Pain in extremity      
# participants affected / at risk     0/311 (0.00%)     4/315 (1.27%)  
# events     0     4  
Pain in jaw      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     5/311 (1.61%)     13/315 (4.13%)  
# events     6     14  
Nervous system disorders      
Balance disorder      
# participants affected / at risk     2/311 (0.64%)     1/315 (0.32%)  
# events     2     1  
Brain oedema      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
CNS ventriculitis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Carotid artery dissection      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Carotid artery thrombosis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Cerebral artery embolism      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cerebral artery occlusion      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cerebral artery stenosis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Cerebral artery thrombosis      
# participants affected / at risk     7/311 (2.25%)     2/315 (0.63%)  
# events     7     2  
Convulsion      
# participants affected / at risk     0/311 (0.00%)     2/315 (0.63%)  
# events     0     2  
Coordination abnormal      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Dizziness      
# participants affected / at risk     3/311 (0.96%)     1/315 (0.32%)  
# events     3     1  
Embolic stroke      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Headache      
# participants affected / at risk     54/311 (17.36%)     57/315 (18.10%)  
# events     59     68  
Hydrocephalus      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hypoaesthesia      
# participants affected / at risk     0/311 (0.00%)     3/315 (0.95%)  
# events     0     3  
Intracranial aneurysm      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Intracranial pressure increased      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Ischaemic stroke      
# participants affected / at risk     3/311 (0.96%)     3/315 (0.95%)  
# events     3     3  
Lethargy      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Memory impairment      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Migraine      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Paraesthesia      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Peroneal nerve palsy      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Ruptured cerebral aneurysm      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Sciatica      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Sensory loss      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Syncope      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Transient ischaemic attack      
# participants affected / at risk     2/311 (0.64%)     4/315 (1.27%)  
# events     2     5  
Tremor      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
VIth nerve paralysis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     73/311 (23.47%)     78/315 (24.76%)  
# events     89     100  
Psychiatric disorders      
Alcohol withdrawal syndrome      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Anxiety      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Confusional state      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Delirium      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Depression      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Insomnia      
# participants affected / at risk     2/311 (0.64%)     0/315 (0.00%)  
# events     2     0  
Mental status changes      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Sleep disorder      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     7/311 (2.25%)     4/315 (1.27%)  
# events     7     4  
Renal and urinary disorders      
Renal failure      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Urethral haemorrhage      
# participants affected / at risk     0/311 (0.00%)     2/315 (0.63%)  
# events     0     2  
Urinary retention      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     0/311 (0.00%)     4/315 (1.27%)  
# events     0     4  
Respiratory, thoracic and mediastinal disorders      
Aspiration      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Dyspnoea      
# participants affected / at risk     2/311 (0.64%)     2/315 (0.63%)  
# events     2     2  
Epistaxis      
# participants affected / at risk     5/311 (1.61%)     2/315 (0.63%)  
# events     5     2  
Haemoptysis      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Pharyngolaryngeal pain      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Pneumonia aspiration      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Total      
# participants affected / at risk     8/311 (2.57%)     7/315 (2.22%)  
# events     8     8  
Skin and subcutaneous tissue disorders      
Alopecia      
# participants affected / at risk     4/311 (1.29%)     4/315 (1.27%)  
# events     4     4  
Ecchymosis      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Increased tendency to bruise      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Rash      
# participants affected / at risk     0/311 (0.00%)     2/315 (0.63%)  
# events     0     2  
Rash generalised      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Swelling face      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Urticaria      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Total      
# participants affected / at risk     6/311 (1.93%)     9/315 (2.86%)  
# events     6     9  
Vascular disorders      
Artery dissection      
# participants affected / at risk     1/311 (0.32%)     1/315 (0.32%)  
# events     1     1  
Blood pressure fluctuation      
# participants affected / at risk     0/311 (0.00%)     1/315 (0.32%)  
# events     0     1  
Hot flush      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Hypertension      
# participants affected / at risk     3/311 (0.96%)     0/315 (0.00%)  
# events     3     0  
Hypotension      
# participants affected / at risk     6/311 (1.93%)     7/315 (2.22%)  
# events     6     7  
Intermittent claudication      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Peripheral artery aneurysm      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Phlebitis      
# participants affected / at risk     1/311 (0.32%)     0/315 (0.00%)  
# events     1     0  
Vasospasm      
# participants affected / at risk     9/311 (2.89%)     8/315 (2.54%)  
# events     9     8  
Total      
# participants affected / at risk     23/311 (7.40%)     17/315 (5.40%)  
# events     23     17  



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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