Trial Outcomes & Findings for SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study (NCT NCT01054560)

Last Updated: 2016-10-26

Results Overview

Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes. Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy. TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

Immediately post treatment

Results posted on

2016-10-26

Participant Flow

Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.

Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.

Participant milestones

Participant milestones
Measure	SOLITAIRE™ Device The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device The MERCI® Device (control device) is commercially available.
Overall Study STARTED	58	55
Overall Study COMPLETED	45	27
Overall Study NOT COMPLETED	13	28

Reasons for withdrawal

Reasons for withdrawal
Measure	SOLITAIRE™ Device The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device The MERCI® Device (control device) is commercially available.
Overall Study Death	10	21
Overall Study Lost to Follow-up	2	5
Overall Study Withdrawal by Subject	0	2
Overall Study Physician Decision	1	0

Baseline Characteristics

SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOLITAIRE™ Device n=58 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=55 Participants The MERCI® Device (control device) is commercially available.	Total n=113 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Age, Continuous	67.1 years STANDARD_DEVIATION 12.0 • n=5 Participants	67.1 years STANDARD_DEVIATION 11.1 • n=7 Participants	67.1 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	54 participants n=7 Participants	111 participants n=5 Participants
Region of Enrollment Europe	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately post treatment

Population: Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=56 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=54 Participants The MERCI® Device (control device) is commercially available.
Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage	60.7 Percent of Subjects	24.1 Percent of Subjects

PRIMARY outcome

Timeframe: 90 Day

Population: Intent-to-treat

Incidence of study device-related Serious Adverse Events (SAEs)

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=58 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=55 Participants The MERCI® Device (control device) is commercially available.
Study Device-related Serious Adverse Events (SAEs)	9 percentage of subjects	16 percentage of subjects

PRIMARY outcome

Timeframe: 90 Day

Population: Intent-to-treat

Incidence of study procedure-related Serious Adverse Events (SAEs)

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=58 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=55 Participants The MERCI® Device (control device) is commercially available.
Procedure-related Serious Adverse Events (SAEs)	14 percentage of subjects	16 percentage of subjects

SECONDARY outcome

Timeframe: post treatment

Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size

Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=47 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=46 Participants The MERCI® Device (control device) is commercially available.
Time to Initial Recanalization	47 minutes Standard Deviation 37.3	58.7 minutes Standard Deviation 33.8

SECONDARY outcome

Timeframe: 30 Days Follow-up

Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.

Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=55 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=51 Participants The MERCI® Device (control device) is commercially available.
Good Neurological Outcome at 30 Days	50.9 Percent of subjects	33.3 Percent of subjects

SECONDARY outcome

Timeframe: 90 Days Follow-up

Population: Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=55 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=48 Participants The MERCI® Device (control device) is commercially available.
Good Neurological Outcome 90 Days	58.2 Percent of subjects	33.3 Percent of subjects

SECONDARY outcome

Timeframe: 90 Days follow-up

Population: Intent-to-treat

Rate of Mortality

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=58 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=55 Participants The MERCI® Device (control device) is commercially available.
Mortality	17.2 Percentage of subjects	38.2 Percentage of subjects

SECONDARY outcome

Timeframe: 24 hours

Population: Intent to treat

Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=58 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=55 Participants The MERCI® Device (control device) is commercially available.
Symptomatic Intracranial Hemorrhage	1.7 Percentage of subjects	10.9 Percentage of subjects

SECONDARY outcome

Timeframe: 90 Day

Population: Intent-to-treat

Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events

Outcome measures

Outcome measures
Measure	SOLITAIRE™ Device n=58 Participants The SOLITAIRE™ Device (investigational device) is the experimental arm	MERCI® Device n=55 Participants The MERCI® Device (control device) is commercially available.
Non-fatal Stroke-related Morbidity	43.1 percentage of subjects	32.7 percentage of subjects

Adverse Events

The SOLITAIRE™ Device

Serious events: 49 serious events

Other events: 37 other events

Deaths: 0 deaths

The MERCI® Device

Serious events: 44 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director of Clinical Affairs

Covidien

Phone: 9498373700

Results disclosure agreements

Principal investigator is a sponsor employee Physician shall not make any publication without providing Sponsor 30 days notice.If Sponsor determines that the proposed publication contains confidential information, Sponsor may require the delay of publication for a period of time not to exceed 90 days and may require that any confidential information be removed from the publication. Sponsor may also require Physician to delay publication until any factual errors or inaccuracies in the publication are corrected.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	The SOLITAIRE™ Device n=58 participants at risk The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device n=55 participants at risk The MERCI® Device (control device) is commercially available.
Blood and lymphatic system disorders Anaemia	15.5% 9/58 • Number of events 10 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	7.3% 4/55 • Number of events 4 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Atrial Fibrillation	19.0% 11/58 • Number of events 12 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	7.3% 4/55 • Number of events 4 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Eye disorders Retinal Artery Occlusion	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Colitis	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Catheter site haematoma	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Injury, poisoning and procedural complications Vascular access complication	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Nervous system disorders Brain oedema	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Renal and urinary disorders Haematuria	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	3.6% 2/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Vascular disorders Air embolism	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Blood and lymphatic system disorders Thrombocytopenia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Atrial Flutter	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Artrioventricular block	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Bradycardyia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	3.6% 2/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Bundle branch block right	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Cardiac disorders	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Cardiac failure congestive	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Tachycardia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Ventricular tachycardia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Acute myocardial	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Arrhythmia	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Cardiac arrest	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	5.5% 3/55 • Number of events 4 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Mitral valve disease	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Sinus bradycardia	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	3.6% 2/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Supraventricular tachycardia	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Eye disorders Vitreous detachment	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Dysphagia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	7.3% 4/55 • Number of events 4 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Gastrointestinal ulcer	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Haematemesis	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Haematochezia	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Intestinal ischaemia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Nausea	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	5.5% 3/55 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Retroperitoneal haematoma	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Device breakage	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Multi-organ failure	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Pyrexia	5.2% 3/58 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	5.5% 3/55 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.

Other adverse events
Measure	The SOLITAIRE™ Device n=58 participants at risk The SOLITAIRE™ Device (investigational device) is the experimental arm	The MERCI® Device n=55 participants at risk The MERCI® Device (control device) is commercially available.
Blood and lymphatic system disorders Anaemia	5.2% 3/58 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	5.5% 3/55 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Adverse drug reaction	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Injury, poisoning and procedural complications Periorbital haematoma	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Blood and lymphatic system disorders Thrombocytopenia	5.2% 3/58 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Bradycardia	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Arrhythmia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Tachycardia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Cardiac failure congestive	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Sinus Bradycardia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Cardiomegaly	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Left ventricular dysfunction	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Eye disorders Conjunctivitis	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Eye disorders Diplopia	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Eye disorders Eye oedema	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Nausea	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	7.3% 4/55 • Number of events 5 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Abdominal pain	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Dysphagia	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Constipation	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	3.6% 2/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Gastrointestinal disorders Colitis ulcerative	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Catheter site haematoma	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Catheter site haemorrhage	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Oedema peripheral	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Pyrexia	6.9% 4/58 • Number of events 4 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	5.5% 3/55 • Number of events 3 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
General disorders Unintentional medical device removal by patient	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Infections and infestations Candidiasis	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Infections and infestations Cellulitis	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	3.6% 2/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Infections and infestations Clostridial infection	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Infections and infestations Oral candidiasis	3.4% 2/58 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Infections and infestations Pneumonia	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	3.6% 2/55 • Number of events 2 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Infections and infestations Urinary tract infection	20.7% 12/58 • Number of events 12 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	10.9% 6/55 • Number of events 7 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Injury, poisoning and procedural complications Laceration	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Injury, poisoning and procedural complications Urinary retention postoperative	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Injury, poisoning and procedural complications Fall	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Investigations Blood bilirubin increased	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Investigations Blood urea increased	1.7% 1/58 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	0.00% 0/55 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.
Investigations Differential white blood cell count abnormal	0.00% 0/58 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.	1.8% 1/55 • Number of events 1 • 90 Days Independent Clinical Events Committee (CEC) provided independent, unbiased and consistent adjudication for all reportable adverse events.