Trial Outcomes & Findings for TAXUS PERSEUS Workhorse (NCT NCT00484315)

NCT ID: NCT00484315

Last Updated: 2014-05-08

Results Overview

The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1264 participants
• Primary outcome timeframe: 12 months post-index procedure
• Results posted on: 2014-05-08

Participant Flow

Enrollment of 1264 subjects was planned; 1262 (942 TAXUS Element and 320 TAXUS Express) were enrolled and randomized at 90 centers by October 1, 2008. A total of 330 subjects were randomly assigned to protocol-mandated 9-month angiographic follow-up (angiographic subset).

Participant milestones

Measure	TAXUS Element Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	TAXUS Express Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
12-Month Clinical Follow-up STARTED	942	320
12-Month Clinical Follow-up COMPLETED	914	311
12-Month Clinical Follow-up NOT COMPLETED	28	9
9-Month Angiographic Follow-up STARTED	256	74
9-Month Angiographic Follow-up COMPLETED	228	61
9-Month Angiographic Follow-up NOT COMPLETED	28	13

Reasons for withdrawal

Measure	TAXUS Element Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	TAXUS Express Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
12-Month Clinical Follow-up Death	6	2
12-Month Clinical Follow-up Withdrawal by Subject	4	0
12-Month Clinical Follow-up Lost to Follow-up	2	1
12-Month Clinical Follow-up Missed 12-Month Visit	13	4
12-Month Clinical Follow-up Withdrawn at Investigator's discretion	3	2
9-Month Angiographic Follow-up No 9-Month Angiography Performed	25	11
9-Month Angiographic Follow-up Not Evaluable for Angiography Analysis	3	2

Baseline Characteristics

TAXUS PERSEUS Workhorse

Baseline characteristics by cohort

Measure	TAXUS Element n=942 Participants Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	TAXUS Express n=320 Participants Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)	Total n=1262 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	540 Participants n=93 Participants	163 Participants n=4 Participants	703 Participants n=27 Participants
Sex: Female, Male Female	275 Participants n=93 Participants	100 Participants n=4 Participants	375 Participants n=27 Participants
Age, Categorical >=65 years	402 Participants n=93 Participants	157 Participants n=4 Participants	559 Participants n=27 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 9.6 • n=93 Participants	63.5 years STANDARD_DEVIATION 9.5 • n=4 Participants	62.5 years STANDARD_DEVIATION 9.6 • n=27 Participants
Sex: Female, Male Male	667 Participants n=93 Participants	220 Participants n=4 Participants	887 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 participants n=93 Participants	6 participants n=4 Participants	16 participants n=27 Participants
Race/Ethnicity, Customized Caucasian	872 participants n=93 Participants	296 participants n=4 Participants	1168 participants n=27 Participants
Race/Ethnicity, Customized Asian	15 participants n=93 Participants	6 participants n=4 Participants	21 participants n=27 Participants
Race/Ethnicity, Customized Black of African heritage	37 participants n=93 Participants	13 participants n=4 Participants	50 participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	4 participants n=93 Participants	1 participants n=4 Participants	5 participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska native	3 participants n=93 Participants	0 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Other	4 participants n=93 Participants	0 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment United States	859 participants n=93 Participants	290 participants n=4 Participants	1149 participants n=27 Participants
Region of Enrollment Singapore	6 participants n=93 Participants	2 participants n=4 Participants	8 participants n=27 Participants
Region of Enrollment Australia	60 participants n=93 Participants	22 participants n=4 Participants	82 participants n=27 Participants
Region of Enrollment New Zealand	17 participants n=93 Participants	6 participants n=4 Participants	23 participants n=27 Participants
Cardiac History Previous Percutaneous Coronary Intervention (PCI)	216 participants n=93 Participants	80 participants n=4 Participants	296 participants n=27 Participants
Cardiac History Previous Coronary Artery Bypass Graft (CABG)	42 participants n=93 Participants	20 participants n=4 Participants	62 participants n=27 Participants
Cardiac History Previous Myocardial Infarction (MI)	195 participants n=93 Participants	60 participants n=4 Participants	255 participants n=27 Participants
Cardiac History Congestive Heart Failure	56 participants n=93 Participants	24 participants n=4 Participants	80 participants n=27 Participants
Cardiac History Stable Angina	629 participants n=93 Participants	213 participants n=4 Participants	842 participants n=27 Participants
Cardiac History Unstable Angina	195 participants n=93 Participants	68 participants n=4 Participants	263 participants n=27 Participants
Cardiac History Silent Ischemia	117 participants n=93 Participants	39 participants n=4 Participants	156 participants n=27 Participants
Cardiac History: Ejection Fraction	58.0 ejection fraction percent STANDARD_DEVIATION 9.3 • n=93 Participants	57.8 ejection fraction percent STANDARD_DEVIATION 9.8 • n=4 Participants	57.9 ejection fraction percent STANDARD_DEVIATION 9.4 • n=27 Participants
Cardiac Risk Factors Smoking, Ever	611 participants n=93 Participants	216 participants n=4 Participants	827 participants n=27 Participants
Cardiac Risk Factors Medically Treated Diabetes	232 participants n=93 Participants	80 participants n=4 Participants	312 participants n=27 Participants
Cardiac Risk Factors Hyperlipidemia Requiring Medication	717 participants n=93 Participants	243 participants n=4 Participants	960 participants n=27 Participants
Cardiac Risk Factors Hypertension Requiring Medication	709 participants n=93 Participants	256 participants n=4 Participants	965 participants n=27 Participants
Cardiac Risk Factors Family History of Coronary Artery Disease	589 participants n=93 Participants	196 participants n=4 Participants	785 participants n=27 Participants
Comorbidities History of Peripheral Vascular Disease	99 participants n=93 Participants	36 participants n=4 Participants	135 participants n=27 Participants
Comorbidities History of Transient Ischemic Attack	30 participants n=93 Participants	14 participants n=4 Participants	44 participants n=27 Participants
Comorbidities History of Cerebrovascular Accident	30 participants n=93 Participants	12 participants n=4 Participants	42 participants n=27 Participants
Comorbidities History of Renal Disease	45 participants n=93 Participants	11 participants n=4 Participants	56 participants n=27 Participants
Comorbidities History of Gastrointestinal Bleeding	9 participants n=93 Participants	7 participants n=4 Participants	16 participants n=27 Participants
Lesion Characteristic: Target Lesion Vessel Left Anterior Descending Artery	406 participants n=93 Participants	140 participants n=4 Participants	546 participants n=27 Participants
Lesion Characteristic: Target Lesion Vessel Left Circumflex Artery	217 participants n=93 Participants	69 participants n=4 Participants	286 participants n=27 Participants
Lesion Characteristic: Target Lesion Vessel Right Coronary Artery	319 participants n=93 Participants	111 participants n=4 Participants	430 participants n=27 Participants
Lesion Characteristic: Lesion Location Ostial	25 participants n=93 Participants	8 participants n=4 Participants	33 participants n=27 Participants
Lesion Characteristic: Lesion Location Proximal	368 participants n=93 Participants	128 participants n=4 Participants	496 participants n=27 Participants
Lesion Characteristic: Lesion Location Mid	485 participants n=93 Participants	154 participants n=4 Participants	639 participants n=27 Participants
Lesion Characteristic: Lesion Location Distal	64 participants n=93 Participants	30 participants n=4 Participants	94 participants n=27 Participants
Lesion Characteristics Reference Vessel Diameter	2.8 millimeter STANDARD_DEVIATION 0.5 • n=93 Participants	2.8 millimeter STANDARD_DEVIATION 0.5 • n=4 Participants	2.8 millimeter STANDARD_DEVIATION 0.5 • n=27 Participants
Lesion Characteristics Minimum Lumen Diameter	0.8 millimeter STANDARD_DEVIATION 0.3 • n=93 Participants	0.8 millimeter STANDARD_DEVIATION 0.4 • n=4 Participants	0.8 millimeter STANDARD_DEVIATION 0.3 • n=27 Participants
Lesion Characteristics Lesion Length	14.2 millimeter STANDARD_DEVIATION 6.1 • n=93 Participants	14.1 millimeter STANDARD_DEVIATION 5.8 • n=4 Participants	14.2 millimeter STANDARD_DEVIATION 6.0 • n=27 Participants
Lesion Characteristics Sidebranch Stenosis	24.4 millimeter STANDARD_DEVIATION 28.1 • n=93 Participants	25.7 millimeter STANDARD_DEVIATION 28.8 • n=4 Participants	24.7 millimeter STANDARD_DEVIATION 28.3 • n=27 Participants
Lesion Characteristic: Percent Diameter Stenosis	72.1 percent STANDARD_DEVIATION 10.9 • n=93 Participants	71.7 percent STANDARD_DEVIATION 10.9 • n=4 Participants	72.0 percent STANDARD_DEVIATION 10.9 • n=27 Participants
Lesion Characteristics Eccentric Lesion	487 participants n=93 Participants	161 participants n=4 Participants	648 participants n=27 Participants
Lesion Characteristics > 45 Degree Bend	61 participants n=93 Participants	22 participants n=4 Participants	83 participants n=27 Participants
Lesion Characteristics > 90 Degree Bend	2 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants
Lesion Characteristics Tortuosity, any	59 participants n=93 Participants	14 participants n=4 Participants	73 participants n=27 Participants
Lesion Characteristics Calcification, any	228 participants n=93 Participants	86 participants n=4 Participants	314 participants n=27 Participants
Lesion Characteristics Total Occlusion	6 participants n=93 Participants	2 participants n=4 Participants	8 participants n=27 Participants
Lesion Characteristics Bifurcation	343 participants n=93 Participants	129 participants n=4 Participants	472 participants n=27 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type A	79 participants n=93 Participants	28 participants n=4 Participants	107 participants n=27 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type B1	233 participants n=93 Participants	85 participants n=4 Participants	318 participants n=27 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type B2	384 participants n=93 Participants	130 participants n=4 Participants	514 participants n=27 Participants
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type C	246 participants n=93 Participants	77 participants n=4 Participants	323 participants n=27 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 0	2 participants n=93 Participants	2 participants n=4 Participants	4 participants n=27 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 1	4 participants n=93 Participants	0 participants n=4 Participants	4 participants n=27 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 2	34 participants n=93 Participants	4 participants n=4 Participants	38 participants n=27 Participants
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 3	902 participants n=93 Participants	314 participants n=4 Participants	1216 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months post-index procedure

Population: The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per protocol analysis set. All randomized participants who had the randomly assigned study stent implanted in the target coronary artery are included.

The number of participants who experience a TLF through 365 days post-procedure out of the participants who have either had a TLF within 365 days post-procedure or who were TLF-free with last follow-up at least 335 days post-procedure.

Outcome measures

Measure	TAXUS Element n=915 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	TAXUS Express n=309 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
Target Lesion Failure (TLF) at 12 Months Post-index Procedure. TLF is Defined as Any Ischemia-driven Revascularization of the Target Lesion, Myocardial Infarction (Q-wave and Non-Q-wave), or Death Related to the Target Vessel.	51 participants	19 participants

SECONDARY outcome

Timeframe: 9 months post-index procedure

Population: All patients from the per protocol analysis set who were randomized to the angiographic subset and completed their angiographic follow-up were analyzed for the secondary endpoint.

The minimum lumen diameter in the analysis segment at 9-months post-index procedure, divided by the reference vessel diameter at baseline. The analysis segment ("in-segment") is defined as the proximal edge, stented area, and the distal edge, where each edge segment contains up to 5mm immediately outside the stent.

Outcome measures

Measure	TAXUS Element n=228 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique	TAXUS Express n=60 Participants Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
In-segment Percent Diameter Stenosis at 9 Months Post-index Procedure	26.1 percent diameter stenosis Standard Deviation 17.71	26.28 percent diameter stenosis Standard Deviation 17.6

Adverse Events

TAXUS Element

Serious events: 334 serious events

Other events: 277 other events

Deaths: 0 deaths

TAXUS Express

Serious events: 110 serious events

Other events: 97 other events

Deaths: 0 deaths

Serious adverse events

Measure	TAXUS Element n=942 participants at risk Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	TAXUS Express n=320 participants at risk Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
Gastrointestinal disorders Splenic artery aneurysm	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Umbilical hernia, obstructive	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Adverse drug reaction	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Catheter site haematoma	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Blood and lymphatic system disorders Anaemia	0.96% 9/942 • Number of events 9 • Site reported serious and non-serious adverse events were collected through 365 days.	1.6% 5/320 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Blood and lymphatic system disorders Microcytic anaemia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Acute coronary syndrome	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Angina pectoris	7.7% 73/942 • Number of events 84 • Site reported serious and non-serious adverse events were collected through 365 days.	8.4% 27/320 • Number of events 28 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Angina unstable	1.9% 18/942 • Number of events 19 • Site reported serious and non-serious adverse events were collected through 365 days.	1.9% 6/320 • Number of events 7 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Arteriospasm coronary	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Atrial fibrillation	1.5% 14/942 • Number of events 16 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Atrial flutter	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Atrial tachycardia	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Atrioventricular block complete	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Bradycardia	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Bundle branch block right	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Cardiac arrest	0.42% 4/942 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Cardiac disorder	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Cardiac failure congestive	0.74% 7/942 • Number of events 8 • Site reported serious and non-serious adverse events were collected through 365 days.	1.6% 5/320 • Number of events 9 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Cardiac tamponade	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Coronary artery disease	0.96% 9/942 • Number of events 9 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Coronary artery dissection	1.1% 10/942 • Number of events 10 • Site reported serious and non-serious adverse events were collected through 365 days.	3.1% 10/320 • Number of events 10 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Coronary artery embolism	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Coronary artery occlusion	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Coronary artery stenosis	1.9% 18/942 • Number of events 19 • Site reported serious and non-serious adverse events were collected through 365 days.	1.6% 5/320 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Coronary artery thrombosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Dressler's syndrome	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Intracardiac thrombus	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Myocardial infarction	2.5% 24/942 • Number of events 24 • Site reported serious and non-serious adverse events were collected through 365 days.	1.6% 5/320 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Myocardial ischaemia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Pericardial effusion	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Pericardial haemorrhage	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Pericarditis	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Sick sinus syndrome	0.64% 6/942 • Number of events 6 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Sinus bradycardia	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Sinus tachycardia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Supraventricular tachycardia	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Tachycardia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Ventricular arrhythmia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Ventricular asystole	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Ventricular extrasystoles	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Ventricular fibrillation	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Cardiac disorders Ventricular tachycardia	0.32% 3/942 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Ear and labyrinth disorders Vertigo	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Endocrine disorders Thyroid mass	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Eye disorders Cataract	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Eye disorders Retinal detachment	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Abdominal distension	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Abdominal pain	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Abdominal pain lower	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Abdominal pain upper	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Anal fistula	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Chronic gastrointestinal bleeding	0.11% 1/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Colitis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Crohn's disease	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Diverticulum	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Erosive duodenitis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Gastric ulcer	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Gastritis	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Gastritis erosive	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.53% 5/942 • Number of events 6 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Hiatus hernia	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Intestinal obstruction	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Melaena	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Pancreatitis acute	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Rectal haemorrhage	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Retroperitoneal haematoma	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Gastrointestinal disorders Small intestinal obstruction	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Catheter site haemorrhage	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Catheter site related reaction	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Chest discomfort	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Chills	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Death	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Non-cardiac chest pain	5.6% 53/942 • Number of events 61 • Site reported serious and non-serious adverse events were collected through 365 days.	4.7% 15/320 • Number of events 18 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Pain	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Pyrexia	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Hepatobiliary disorders Cholecystitis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Hepatobiliary disorders Cholecystitis acute	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Hepatobiliary disorders Cholelithiasis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Immune system disorders Anaphylactic reaction	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Immune system disorders Anaphylactoid reaction	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Immune system disorders Drug hypersensitivity	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Acinetobacter bacteraemia	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Beta haemolytic streptococcal infection	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Bronchitis	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Cellulitis	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	1.2% 4/320 • Number of events 6 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Device related infection	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Empyema	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Endocarditis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Gastroenteritis	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Gastroenteritis viral	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Lobar pneumonia	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Orchitis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Osteomyelitis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Perirectal abscess	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Pneumonia	0.96% 9/942 • Number of events 9 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Pneumonia bacterial	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Postoperative wound infection	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Sepsis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Staphylococcal infection	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Tooth abscess	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Urinary tract infection	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Viral infection	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Infections and infestations Wound infection	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Anastomotic ulcer	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Back injury	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Cardiac procedure complication	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Contrast media reaction	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Contusion	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Facial bones fracture	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Fall	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Foot fracture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Hand fracture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Hip fracture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Joint injury	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Laceration	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Ligament rupture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Limb injury	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Meniscus lesion	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Multiple fractures	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Renal injury	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Road traffic accident	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Skin laceration	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Subdural haematoma	0.11% 1/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Tendon rupture	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Wound	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Injury, poisoning and procedural complications Wound complication	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Blood creatine phosphokinase MB increased	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Blood creatine phosphokinase increased	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Blood pressure increased	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Cardiac enzymes increased	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Ejection fraction decreased	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations International normalised ratio increased	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Troponin I increased	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations Troponin increased	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Investigations White blood cell count increased	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Dehydration	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.11% 1/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Diabetic foot	0.11% 1/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Gout	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Hyperkalaemia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Hypoglycaemia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Metabolism and nutrition disorders Obesity	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Arthralgia	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Arthritis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Arthropathy	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Back pain	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Muscle spasms	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Muscular weakness	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.21% 2/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Carotid artery stenosis	0.42% 4/942 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Cerebrovascular accident	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Convulsion	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Dizziness	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Embolic stroke	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Haemorrhage intracranial	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Headache	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Hydrocephalus	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Loss of consciousness	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Nerve compression	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Presyncope	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Subarachnoid haemorrhage	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Syncope	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Syncope vasovagal	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Nervous system disorders Transient ischaemic attack	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.
Psychiatric disorders Mental status changes	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Haematuria	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Nephrolithiasis	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Nephropathy toxic	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Renal artery stenosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Renal failure	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Renal failure acute	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Renal and urinary disorders Urinary retention	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Reproductive system and breast disorders Prostatitis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.53% 5/942 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.74% 7/942 • Number of events 7 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.11% 1/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Laryngeal mass	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.11% 1/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.21% 2/942 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.	0.94% 3/320 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.21% 2/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Surgical and medical procedures Spinal decompression	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Aortic aneurysm	0.21% 2/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Aortic stenosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Arterial thrombosis limb	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Coronary artery stenosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Deep vein thrombosis	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Femoral arterial stenosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Haematoma	0.32% 3/942 • Number of events 3 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Hypertension	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Hypotension	0.42% 4/942 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Intermittent claudication	1.1% 10/942 • Number of events 11 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Myocardial infarction	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Orthostatic hypotension	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Peripheral artery dissection	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Peripheral vascular disorder	0.42% 4/942 • Number of events 5 • Site reported serious and non-serious adverse events were collected through 365 days.	1.2% 4/320 • Number of events 4 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Phlebitis	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Phlebitis superficial	0.00% 0/942 • Site reported serious and non-serious adverse events were collected through 365 days.	0.31% 1/320 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Subclavian artery stenosis	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Thrombophlebitis superficial	0.11% 1/942 • Number of events 1 • Site reported serious and non-serious adverse events were collected through 365 days.	0.00% 0/320 • Site reported serious and non-serious adverse events were collected through 365 days.
Vascular disorders Vascular pseudoaneurysm	0.74% 7/942 • Number of events 7 • Site reported serious and non-serious adverse events were collected through 365 days.	0.62% 2/320 • Number of events 2 • Site reported serious and non-serious adverse events were collected through 365 days.

Other adverse events

Measure	TAXUS Element n=942 participants at risk Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)	TAXUS Express n=320 participants at risk Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
Cardiac disorders Angina pectoris	10.4% 98/942 • Number of events 114 • Site reported serious and non-serious adverse events were collected through 365 days.	12.5% 40/320 • Number of events 44 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Catheter site haematoma	4.9% 46/942 • Number of events 47 • Site reported serious and non-serious adverse events were collected through 365 days.	5.9% 19/320 • Number of events 22 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Catheter site haemorrhage	3.0% 28/942 • Number of events 28 • Site reported serious and non-serious adverse events were collected through 365 days.	5.0% 16/320 • Number of events 18 • Site reported serious and non-serious adverse events were collected through 365 days.
General disorders Non-cardiac chest pain	12.7% 120/942 • Number of events 150 • Site reported serious and non-serious adverse events were collected through 365 days.	10.0% 32/320 • Number of events 36 • Site reported serious and non-serious adverse events were collected through 365 days.
Musculoskeletal and connective tissue disorders Back pain	5.8% 55/942 • Number of events 56 • Site reported serious and non-serious adverse events were collected through 365 days.	5.6% 18/320 • Number of events 19 • Site reported serious and non-serious adverse events were collected through 365 days.

Additional Information

Andrey Nersesov, Clinical Project Manager

Boston Scientific

Phone: 508-683-4988

Email: andrey.nersesov@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
• Publication restrictions are in place

Restriction type: OTHER