Trial Outcomes & Findings for Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) (NCT NCT03071692)

NCT ID: NCT03071692

Last Updated: 2025-09-25

Results Overview

Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint, which includes nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, or cardiovascular (CV) death. Each participant is counted only once, regardless of any subsequent events.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 10544 participants
• Primary outcome timeframe: From Baseline to a Median of 3.3 Years
• Results posted on: 2025-09-25

Participant Flow

Prior to treatment, participants attended a Prescreening Visit, a Screening/Enrollment Visit and a Placebo Run-In Period. Eligible subjects who were compliant with study treatment during the Placebo Run-In Period returned for the Randomization Visit, at which time they were randomly allocated to receive either pemafibrate or a matching placebo tablet.

Participant milestones

Measure	Pemafibrate Participants receiving K-877 tablets administered twice daily.	Placebo Participants receiving Placebo matching tablet twice daily.
Overall Study STARTED	5269	5275
Overall Study COMPLETED	4647	4674
Overall Study NOT COMPLETED	622	601

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

Baseline characteristics by cohort

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.	Total n=10497 Participants Total of all reporting groups
Age, Continuous	63.28 Years STANDARD_DEVIATION 8.524 • n=5 Participants	63.56 Years STANDARD_DEVIATION 8.411 • n=7 Participants	63.42 Years STANDARD_DEVIATION 8.468 • n=5 Participants
Sex: Female, Male Female	1443 Participants n=5 Participants	1448 Participants n=7 Participants	2891 Participants n=5 Participants
Sex: Female, Male Male	3797 Participants n=5 Participants	3809 Participants n=7 Participants	7606 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1014 Participants n=5 Participants	1007 Participants n=7 Participants	2021 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4187 Participants n=5 Participants	4213 Participants n=7 Participants	8400 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Race/Ethnicity, Customized White	4484 Participants n=5 Participants	4549 Participants n=7 Participants	9033 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	134 Participants n=5 Participants	136 Participants n=7 Participants	270 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	73 Participants n=5 Participants	76 Participants n=7 Participants	149 Participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	97 Participants n=5 Participants	80 Participants n=7 Participants	177 Participants n=5 Participants
Race/Ethnicity, Customized Bangladeshi	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Filipino	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	162 Participants n=5 Participants	146 Participants n=7 Participants	308 Participants n=5 Participants
Race/Ethnicity, Customized Korean	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Pakistani	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Vietnamese	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other Asian	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Guamanian or Chamorro	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Samoan	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized Other	208 Participants n=5 Participants	201 Participants n=7 Participants	409 Participants n=5 Participants
Race/Ethnicity, Customized Declined	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Cardiovascular Diseases and Risk Factors at Baseline Statin Status · No	220 Participants n=5 Participants	219 Participants n=7 Participants	439 Participants n=5 Participants
Cardiovascular Diseases and Risk Factors at Baseline Statin Status · Yes	5020 Participants n=5 Participants	5038 Participants n=7 Participants	10058 Participants n=5 Participants
Cardiovascular Diseases and Risk Factors at Baseline Established CV Disease · No	1695 Participants n=5 Participants	1713 Participants n=7 Participants	3408 Participants n=5 Participants
Cardiovascular Diseases and Risk Factors at Baseline Established CV Disease · Yes	3545 Participants n=5 Participants	3544 Participants n=7 Participants	7089 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: Intention to treat population (ITT)

Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint, which includes nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, or cardiovascular (CV) death. Each participant is counted only once, regardless of any subsequent events.

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Coronary Revascularization, or CV Death)	590 participants	570 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT population

The 4-component composite secondary endpoints events are nonfatal myocardial infarction, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or cardiovascular death

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of the 4-component Composite Secondary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Hospitalization for Unstable Angina Requiring Unplanned Coronary Revascularization, or CV Death)	447 participants	427 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT population

Number of Participants with First Occurrence of Composite Cardiovascular Events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death)

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of the 3-component Composite Endpoint (Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Death)	396 participants	386 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT Population

Event is the first occurrence of any component of the composite endpoint of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, cardiovascular death, or hospitalization for heart failure

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of Any Component of the Primary Endpoint or Hospitalization for Heart Failure	670 participants	645 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT Population

Event is the first occurrence of any component of the composite endpoint of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, cardiovascular death, or all-cause mortality.

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With Occurrence of Any Component of the Primary Endpoint or All-Cause Mortality	830 participants	806 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT Population

Total number of events for the 4-component composite primary endpoint, counting all occurrences, including multiple events in the same participant. The endpoint events include nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, and cardiovascular (CV) death.

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Total Number of Events of the 4-component Composite Primary Endpoint	895 Events	892 Events

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT Population

Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing (eg, toe-brachial index, angiogram, or other imaging study)

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of Any New or Worsening Peripheral Artery Disease (PAD)	138 participants	159 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT Population

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of Nonfatal Myocardial Infarction	210 participants	182 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT population

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of Nonfatal Ischemic Stroke	96 participants	106 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT population

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of Coronary Revascularization	340 participants	347 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: ITT Population

Outcome measures

Measure	Pemafibrate n=5240 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=5257 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of Cardiovascular Death	145 participants	139 participants

SECONDARY outcome

Timeframe: From Baseline to a Median of 3.3 Years

Population: This analysis includes participants from the intent-to-treat population who consented to genetic testing for the PPAR-α gene. Participants who did not provide consent for genetic testing are excluded from the numbers reported for this outcome measure.

Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint (nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, or cardiovascular death), reported as a subgroup analysis by PPAR-α gene variants (TT, CT, CC).

Outcome measures

Measure	Pemafibrate n=2800 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=2841 Participants Participants receiving Placebo matching tablet twice daily.
Number of Participants With First Occurrence of the 4-component Composite Endpoint by PPAR-α Gene Variant Subgroup (TT, CT, CC) TT variant	114 Count of Participants	117 Count of Participants
Number of Participants With First Occurrence of the 4-component Composite Endpoint by PPAR-α Gene Variant Subgroup (TT, CT, CC) CT variant	177 Count of Participants	156 Count of Participants
Number of Participants With First Occurrence of the 4-component Composite Endpoint by PPAR-α Gene Variant Subgroup (TT, CT, CC) CC variant	63 Count of Participants	65 Count of Participants

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4859 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4899 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Total Cholesterol (TC)	5.235 Percent Change Standard Deviation 23.7683	4.562 Percent Change Standard Deviation 23.9991

SECONDARY outcome

Timeframe: Baseline to 4 Months

Population: * ITT Population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4814 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4848 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Fasting Triglycerides	-23.860 Percent Change Standard Deviation 49.2289	2.593 Percent Change Standard Deviation 60.6399

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4858 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4896 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for HDL - Cholesterol (HDL-C)	10.856 Percent Change Standard Deviation 24.7407	6.004 Percent Change Standard Deviation 21.7838

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4858 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4896 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Calculated Non-HDL Cholesterol (Non-HDL-C)	5.219 Percent Change Standard Deviation 31.9262	5.502 Percent Change Standard Deviation 31.9739

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=3841 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=3614 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Calculated VLDL Cholesterol	-22.788 Percent Change Standard Deviation 32.5741	-1.601 Percent Change Standard Deviation 36.4352

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4807 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4847 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Apolipoprotein A1 (ApoA1)	4.878 Percent Change Standard Deviation 19.3749	3.956 Percent Change Standard Deviation 18.5293

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4783 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4808 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Apolipoprotein CIII (ApoC3)	-23.397 Percent Change Standard Deviation 31.5756	4.861 Percent Change Standard Deviation 56.0921

SECONDARY outcome

Timeframe: Baseline to Month 4

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4801 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4842 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 4 for Apolipoprotein E (ApoE)	-6.5201 Percent Change Standard Deviation 30.89475	-0.5209 Percent Change Standard Deviation 31.79989

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: * ITT population * The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including: * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.

Outcome measures

Measure	Pemafibrate n=4614 Participants Participants receiving K-877 tablets administered twice daily.	Placebo n=4643 Participants Participants receiving Placebo matching tablet twice daily.
Percent Change From Baseline to Month 6 for Non-fasting Remnant Cholesterol	-21.27 Percent Change Standard Deviation 46.506	10.60 Percent Change Standard Deviation 54.029

Adverse Events

Pemafibrate

Serious events: 1715 serious events

Other events: 2817 other events

Deaths: 308 deaths

Placebo

Serious events: 1663 serious events

Other events: 2883 other events

Deaths: 310 deaths

Serious adverse events

Measure	Pemafibrate n=5264 participants at risk Participants receiving K-877 tablets administered twice daily.	Placebo n=5274 participants at risk Participants receiving Placebo matching tablet twice daily.
Vascular disorders Peripheral vascular disorder	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Diabetic vascular disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Dry gangrene	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypovolaemic shock	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Venous thrombosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Arterial thrombosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Distributive shock	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Embolism arterial	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Pelvic venous thrombosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Shock haemorrhagic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Thrombosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Varicose vein	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aneurysm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic aneurysm rupture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic arteriosclerosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic dissection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic occlusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic thrombosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Arterial insufficiency	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Arterial occlusive disease	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Arterial stenosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Haematoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Circulatory collapse	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypertensive urgency	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Arteriosclerosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Femoral artery aneurysm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Haemorrhagic infarction	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Iliac artery dissection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Iliac artery occlusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Orthostatic hypotension	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Peripheral artery occlusion	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Peripheral artery thrombosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic aneurysm	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypertensive emergency	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.19% 10/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Blood loss anaemia	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Hypochromic anaemia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Pancytopenia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Normocytic anaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Blood and lymphatic system disorders Pernicious anaemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Angina unstable	1.8% 97/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.8% 95/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Acute myocardial infarction	1.8% 97/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.8% 93/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac failure	1.6% 84/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.3% 68/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Angina pectoris	1.3% 69/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.1% 59/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrial fibrillation	1.0% 53/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.4% 73/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery disease	1.3% 66/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.1% 59/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Myocardial infarction	1.1% 56/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.1% 58/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.85% 45/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.0% 55/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery stenosis	0.61% 32/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.63% 33/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac failure acute	0.36% 19/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.30% 16/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Myocardial ischaemia	0.25% 13/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.42% 22/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrial flutter	0.21% 11/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.34% 18/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac failure chronic	0.27% 14/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.28% 15/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Ventricular tachycardia	0.23% 12/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Arteriosclerosis coronary artery	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.21% 11/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery occlusion	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.23% 12/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Acute left ventricular failure	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Acute coronary syndrome	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrioventricular block complete	0.17% 9/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Aortic valve stenosis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Bradycardia	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Left ventricular failure	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Arrhythmia	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrioventricular block second degree	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac arrest	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Sinus node dysfunction	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Supraventricular tachycardia	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Pericarditis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Ventricular fibrillation	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrioventricular block	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Left ventricular dysfunction	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Palpitations	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrial tachycardia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Bundle branch block left	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardio-respiratory arrest	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Ischaemic cardiomyopathy	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Ventricular extrasystoles	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Aortic valve incompetence	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrial thrombosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac ventricular thrombosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery insufficiency	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Mitral valve stenosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Myocarditis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Right ventricular failure	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Sinus arrest	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Sinus bradycardia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Supraventricular extrasystoles	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Aortic valve calcification	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Aortic valve disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Arteriospasm coronary	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Atrioventricular block first degree	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac aneurysm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiac tamponade	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiogenic shock	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiomyopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiorenal syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cardiovascular disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Chronic coronary syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Conduction disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Congestive cardiomyopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Cor pulmonale acute	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery dissection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery perforation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Coronary artery thrombosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Degenerative aortic valve disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Hypertensive heart disease	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Low cardiac output syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Microvascular coronary artery disease	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Mitral valve incompetence	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Nodal rhythm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Pericardial effusion	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Postinfarction angina	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Prinzmetal angina	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Sinus tachycardia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Stress cardiomyopathy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Tachyarrhythmia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Cardiac disorders Ventricular arrhythmia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Rathke's cleft cyst	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Congenital megaureter	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Keratosis follicular	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Oesophageal cyst	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Skeletal dysplasia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Congenital, familial and genetic disorders Venous angioma of brain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Ear and labyrinth disorders Vertigo	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Ear and labyrinth disorders Sudden hearing loss	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Endocrine disorders Goitre	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Endocrine disorders Primary hyperaldosteronism	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Endocrine disorders Hyperparathyroidism	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Endocrine disorders Hyperparathyroidism primary	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Endocrine disorders Hyperthyroidism	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Endocrine disorders Thyroid mass	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Cataract	0.28% 15/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.25% 13/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Retinal detachment	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Vitreous haemorrhage	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Glaucoma	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Strabismus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Tractional retinal detachment	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Cataract nuclear	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Diabetic retinopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Diplopia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Dry eye	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Exophthalmos	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Iridocele	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Iris neovascularisation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Macular fibrosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Macular hole	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Papilloedema	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Retinal tear	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Uveitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Visual acuity reduced	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Vitreoretinal traction syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Vitreous detachment	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Eye disorders Vitreous disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.28% 15/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.23% 12/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Pancreatitis acute	0.30% 16/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Small intestinal obstruction	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Large intestine polyp	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastritis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Intestinal obstruction	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastritis erosive	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Obstructive pancreatitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Vomiting	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Colitis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Constipation	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastric ulcer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oesophageal spasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Pancreatitis chronic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Umbilical hernia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Anal fistula	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Colitis ulcerative	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Diverticulum	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Duodenal ulcer	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Duodenitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Ileus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Incarcerated umbilical hernia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Intestinal ischaemia	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Abdominal hernia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Ascites	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Colitis ischaemic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Crohn's disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Diverticulum intestinal	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Dysphagia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Enterocolitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Faecaloma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Hiatus hernia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Impaired gastric emptying	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Incarcerated inguinal hernia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Intestinal perforation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Mechanical ileus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oesophageal stenosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Proctitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Rectal haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Anal haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Anal skin tags	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Anal stenosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Barrett's oesophagus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Chronic gastritis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Diverticular perforation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Duodenal perforation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Enteritis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Eosinophilic oesophagitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastric disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastric ulcer perforation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastroduodenal haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Gastrointestinal wall thickening	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Haematochezia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Inguinal hernia strangulated	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Intestinal haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Intestinal mass	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Large intestinal haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Large intestine perforation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Melaena	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Nausea	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Obstruction gastric	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oedematous pancreatitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oesophageal achalasia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Oesophagitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Peptic ulcer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Pneumoretroperitoneum	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Rectal polyp	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Rectal prolapse	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Retroperitoneal effusion	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Salivary gland mass	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Short-bowel syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Small intestinal haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Small intestinal perforation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Small intestine ulcer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Splenic artery aneurysm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Stomatitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Gastrointestinal disorders Subileus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Non-cardiac chest pain	0.57% 30/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.72% 38/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Chest pain	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Vascular stent stenosis	0.17% 9/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Asthenia	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Multiple organ dysfunction syndrome	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Pyrexia	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Oedema peripheral	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Fatigue	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Gait disturbance	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Impaired healing	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Vascular device occlusion	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Catheter site inflammation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Chest discomfort	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Drug intolerance	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Exercise tolerance decreased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Hernia pain	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Localised oedema	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Iliac artery stenosis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Malaise	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Peripheral swelling	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Physical deconditioning	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Prosthetic cardiac valve stenosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Stenosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Strangulated hernia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Systemic inflammatory response syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
General disorders Vascular stent thrombosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Cholelithiasis	0.44% 23/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.27% 14/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Cholecystitis	0.28% 15/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.28% 15/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Cholecystitis acute	0.28% 15/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Bile duct stone	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Biliary obstruction	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Cholecystitis chronic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hepatic cirrhosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Jaundice cholestatic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Biliary colic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Cholangitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hepatic mass	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Nonalcoholic fatty liver disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Acute hepatic failure	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Cholangitis acute	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Drug-induced liver injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Gallbladder oedema	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hepatic fibrosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hepatitis cholestatic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Anaphylactic reaction	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Amyloidosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Contrast media allergy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Cytokine storm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Food allergy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Hypersensitivity	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Immune system disorders Sarcoidosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations COVID-19 pneumonia	1.8% 95/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.7% 91/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia	1.6% 82/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.6% 87/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations COVID-19	1.1% 57/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.95% 50/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Coronavirus infection	0.80% 42/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.61% 32/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Extremity necrosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cellulitis	0.57% 30/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.53% 28/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Sepsis	0.59% 31/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.47% 25/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Urinary tract infection	0.38% 20/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.66% 35/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Osteomyelitis	0.30% 16/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.32% 17/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Diverticulitis	0.27% 14/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gastroenteritis	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.25% 13/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Appendicitis	0.19% 10/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Erysipelas	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.23% 12/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Urosepsis	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.23% 12/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Influenza	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gangrene	0.17% 9/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pyelonephritis	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Septic shock	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bronchitis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Lower respiratory tract infection	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Escherichia sepsis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Localised infection	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cystitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Device related infection	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Diabetic foot infection	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pyelonephritis acute	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Wound infection	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Abscess limb	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bacteraemia	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Anal abscess	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cholecystitis infective	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Clostridium difficile colitis	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Escherichia urinary tract infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Post procedural infection	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Herpes zoster	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia bacterial	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Postoperative wound infection	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bacterial sepsis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Infection	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia viral	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pulmonary sepsis	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pyelonephritis chronic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Streptococcal sepsis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Abdominal abscess	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Arthritis bacterial	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Arthritis infective	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Atypical pneumonia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bacterial pyelonephritis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Breast abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Dengue fever	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Diabetic gangrene	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Empyema	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Escherichia bacteraemia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Fournier's gangrene	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gastroenteritis bacterial	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Helicobacter gastritis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Intervertebral discitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Lung abscess	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumococcal sepsis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Subcutaneous abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Appendicitis perforated	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bursitis infective	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cellulitis staphylococcal	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cellulitis streptococcal	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Clostridium difficile infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Emphysematous cystitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Escherichia infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gastroenteritis rotavirus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gastroenteritis viral	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Groin abscess	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Implant site infection	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Infected skin ulcer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Klebsiella sepsis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Liver abscess	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Lyme disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Mastoiditis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Mediastinitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Otitis externa	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pelvic abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Peritonitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Rectal abscess	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Respiratory syncytial virus infection	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Respiratory tract infection	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Sinusitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Soft tissue infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Staphylococcal bacteraemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Staphylococcal osteomyelitis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Staphylococcal sepsis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Urinary tract infection bacterial	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Wound sepsis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Abdominal sepsis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Abdominal wall abscess	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Abscess neck	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Actinomycotic pulmonary infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Acute hepatitis B	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Alpha haemolytic streptococcal infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Anorectal cellulitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bacterial tracheitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bartholinitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Brain abscess	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bronchitis viral	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Bullous erysipelas	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Candida infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Chest wall abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Chikungunya virus infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cholangitis infective	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Chronic sinusitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Clostridium colitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Cyclosporidium infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Dengue haemorrhagic fever	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Diverticulitis intestinal perforated	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Ear infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Ear infection viral	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Eczema herpeticum	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Eczema infected	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Emphysematous pyelonephritis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Enterobacter pneumonia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Enterococcal bacteraemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Enterococcal infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Epididymitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Epstein-Barr virus infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Extradural abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gallbladder empyema	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Gastric infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Graft infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Groin infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Haematoma infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations HCoV-HKU1 infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Hepatitis B	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Hepatitis viral	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Herpes zoster oticus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Infected dermal cyst	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Infectious mononucleosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Infectious pleural effusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Intestinal sepsis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Klebsiella infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Labyrinthitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Large intestine infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Lymph node tuberculosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Mastitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Meningococcal infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Meningoencephalitis bacterial	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Metapneumovirus pneumonia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Myelitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Necrotising fasciitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Neutropenic sepsis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Oesophageal candidiasis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Ophthalmic herpes zoster	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Oral candidiasis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Orchitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Osteomyelitis bacterial	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Otitis media acute	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Otitis media chronic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Paronychia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Perichondritis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Periorbital cellulitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Peritonsillar abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia fungal	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia legionella	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia necrotising	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia pneumococcal	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia pseudomonal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Post procedural sepsis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pseudomembranous colitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pseudomonas infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Pulmonary tuberculosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Respiratory tract infection bacterial	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Rhinitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Septic arthritis staphylococcal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Serratia infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Sialoadenitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Skin infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Splenic abscess	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Staphylococcal infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Streptococcal abscess	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Streptococcal bacteraemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Streptococcal infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Tooth abscess	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Tooth infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Tracheobronchitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Vaginal infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Vascular device infection	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Viral infection	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Viral sepsis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Wound infection staphylococcal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Fall	0.17% 9/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Ankle fracture	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Hip fracture	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Femur fracture	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Limb injury	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Lower limb fracture	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Rib fracture	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Humerus fracture	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Tendon rupture	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Toxicity to various agents	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Concussion	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Hand fracture	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Head injury	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Coronary artery restenosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Craniocerebral injury	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Intentional overdose	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Meniscus injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Wrist fracture	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Contusion	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Overdose	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Pelvic fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Procedural pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Radius fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Tibia fracture	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Chest injury	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Incisional hernia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Postoperative wound complication	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Skin laceration	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Accidental overdose	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Animal bite	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Arterial injury	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Burns third degree	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Injury	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Jaw fracture	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Joint dislocation	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Intermittent claudication	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Muscle rupture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Scapula fracture	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Subdural haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Traumatic haematoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Accident at work	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Adjacent segment degeneration	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Arteriovenous fistula maturation failure	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Bite	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Bone fissure	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Burns second degree	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Cardiac contusion	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Cardiac function disturbance postoperative	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Cataract operation complication	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Clavicle fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Costal cartilage fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Gun shot wound	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Heat exhaustion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Heat illness	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Incision site impaired healing	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Intervertebral disc injury	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Joint injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Ligament rupture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Lip injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Osteophyte fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Peripheral artery restenosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Periprosthetic fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Post concussion syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Post procedural haematoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Postoperative renal failure	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Procedural haemorrhage	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Seroma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Shunt thrombosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Soft tissue injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Spinal cord injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Spinal fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Tendon injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Traumatic fracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Vascular pseudoaneurysm ruptured	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications VIth nerve injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Wound	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Wound complication	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations SARS-CoV-2 test positive	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood glucose increased	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood pressure increased	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Catheterisation cardiac	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Alanine aminotransferase increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood urea increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Ejection fraction decreased	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Glomerular filtration rate decreased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Liver function test increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Prostatic specific antigen increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Transaminases increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Albumin urine present	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Anticoagulation drug level above therapeutic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood alkaline phosphatase increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood creatine phosphokinase increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood creatinine increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Blood iron decreased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Cardioactive drug level below therapeutic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Device function test	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Electrocardiogram ST segment elevation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Glycosylated haemoglobin increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Heart rate increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Heart rate irregular	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Hepatic enzyme increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations International normalised ratio increased	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Myocardial necrosis marker increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Oxygen saturation decreased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Protein urine present	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Scan myocardial perfusion abnormal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Troponin increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Urine albumin/creatinine ratio increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Investigations Vitamin B1 decreased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.59% 31/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.40% 21/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.36% 19/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.36% 19/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.27% 14/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.23% 12/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Obesity	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Gout	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Diabetic complication	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Fluid overload	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hyperlipidaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Metabolic syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.70% 37/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.72% 38/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.32% 17/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Costochondritis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Periarthritis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Arthropathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Back disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Chondropathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Connective tissue inflammation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Fasciitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Femoroacetabular impingement	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Foot deformity	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in jaw	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal ligament ossification	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Spondylitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Tendon pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.49% 26/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.57% 30/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma recurrent	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteral neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of appendix	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign small intestinal neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage 0, with cancer in situ	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma metastatic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic naevus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage II	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epithelioid sarcoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Peripheral artery aneurysm	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease mixed cellularity stage III	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary-mucinous carcinoma of pancreas	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mediastinal neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage III	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paranasal sinus neoplasm	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic adenoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prolactin-producing pituitary tumour	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage I	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage II	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage II	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer extensive stage	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue sarcoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the parotid gland	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Synovial sarcoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular leiomyosarcoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma metastatic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Ischaemic stroke	0.99% 52/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.0% 53/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebrovascular accident	0.49% 26/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.47% 25/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Syncope	0.51% 27/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.40% 21/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Transient ischaemic attack	0.38% 20/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.40% 21/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid artery stenosis	0.23% 12/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.21% 11/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebral infarction	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Diabetic neuropathy	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Seizure	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebrovascular disorder	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Encephalopathy	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Headache	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Dizziness	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hemiparesis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Lacunar stroke	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Embolic stroke	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Lacunar infarction	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Presyncope	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid artery occlusion	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebral haemorrhage	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Lumbar radiculopathy	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Subarachnoid haemorrhage	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Altered state of consciousness	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Bell's palsy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebellar infarction	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebellar stroke	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cervical radiculopathy	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Haemorrhagic stroke	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Intracranial aneurysm	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Loss of consciousness	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Metabolic encephalopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Sciatica	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Balance disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Brain stem stroke	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carpal tunnel syndrome	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cognitive disorder	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Epilepsy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Myelopathy	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Quadriplegia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Radiculopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Thrombotic stroke	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Toxic encephalopathy	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Anosmia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Aphasia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Ataxia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Brain stem infarction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid artery aneurysm	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid artery disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid artery insufficiency	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Carotid sinus syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cauda equina syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Central nervous system lesion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebellar syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebral arteriosclerosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebral ischaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebral microangiopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cerebrovascular insufficiency	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Cervical cord compression	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Colloid brain cyst	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Coma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Coordination abnormal	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Depressed level of consciousness	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Dysarthria	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Encephalomalacia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Facial paralysis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Haemorrhage intracranial	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Haemorrhagic transformation stroke	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hemiplegia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hepatic encephalopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hydrocephalus	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hypoaesthesia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hypoglycaemic encephalopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hypoglycaemic seizure	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hypotonia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Intracranial pressure increased	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Ischaemic cerebral infarction	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Monoparesis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Nystagmus	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Ophthalmic migraine	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Optic neuritis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Paraparesis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Parkinson's disease	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Partial seizures	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Postresuscitation encephalopathy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Psychomotor hyperactivity	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Restless legs syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Reversible cerebral vasoconstriction syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Spinal cord compression	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Spinal cord haematoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Spinal cord herniation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Spinal cord infarction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Status migrainosus	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Tension headache	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Transient global amnesia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Tremor	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Uraemic encephalopathy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Vascular dementia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Vascular parkinsonism	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Vertebral artery occlusion	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Vertebrobasilar insufficiency	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Vertebrobasilar stroke	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders VIth nerve paralysis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders VIth nerve paresis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device malfunction	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device power source issue	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Lead dislodgement	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device breakage	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device dislocation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device electrical impedance issue	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device fastener issue	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Product Issues Device occlusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Depression	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Delirium	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Anxiety	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Major depression	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Suicidal ideation	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Disorientation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Mental status changes	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Suicide attempt	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Bipolar disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Confusional state	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Schizophrenia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Conversion disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Insomnia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Mental disorder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Panic attack	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Psychotic disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Sleep disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Psychiatric disorders Suspected suicide	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Acute kidney injury	1.3% 66/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.80% 42/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Nephrolithiasis	0.25% 13/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.30% 16/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Chronic kidney disease	0.21% 11/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal failure	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Urinary retention	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Ureterolithiasis	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.13% 7/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Diabetic nephropathy	0.17% 9/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Calculus urinary	0.11% 6/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Haematuria	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal impairment	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Hydronephrosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders End stage renal disease	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Proteinuria	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Urethral stenosis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Calculus bladder	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal artery stenosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal cyst	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Urinary tract obstruction	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Bladder tamponade	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Nephrotic syndrome	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal colic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Ureteric stenosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Azotaemia	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Bladder prolapse	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Cystitis haemorrhagic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Glomerulonephritis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Haemorrhage urinary tract	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Hypertonic bladder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Nephropathy toxic	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Nephrosclerosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal haematoma	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal mass	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Renal tubular injury	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Stag horn calculus	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Tubulointerstitial nephritis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Ureteric obstruction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Urethral meatus stenosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Urinary bladder varices	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Urinary incontinence	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.32% 17/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.25% 13/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Prostatitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.08% 4/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Uterine polyp	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Acquired hydrocele	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Adnexa uteri mass	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Penile haematoma	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Penile necrosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.44% 23/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.28% 15/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.42% 22/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.30% 16/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.51% 27/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.28% 15/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.27% 14/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.08% 4/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.13% 7/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.09% 5/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.06% 3/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary cavitation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.04% 2/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.04% 2/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Aorto-bronchial fistula	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal cavity mass	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Paraneoplastic pleural effusion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal cyst	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord cyst	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord thickening	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Diabetic foot	0.28% 15/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.17% 9/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Angioedema	0.06% 3/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Necrotic angiodermatitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Skin necrosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Skin and subcutaneous tissue disorders Urticaria	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Social circumstances Death of relative	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Social circumstances Housebound	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Surgical and medical procedures Cardiac pacemaker replacement	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Surgical and medical procedures Hysterosalpingo-oophorectomy	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Surgical and medical procedures Limb amputation	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Peripheral arterial occlusive disease	0.70% 37/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	1.1% 60/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypertensive crisis	0.25% 13/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.32% 17/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypertension	0.36% 19/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Aortic stenosis	0.23% 12/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.17% 9/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Deep vein thrombosis	0.23% 12/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypotension	0.15% 8/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.19% 10/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Peripheral ischaemia	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.15% 8/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Peripheral artery stenosis	0.09% 5/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.11% 6/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Infarction	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Ischaemia	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Ischaemic limb pain	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Leriche syndrome	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Neurogenic shock	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Phlebitis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Subclavian artery stenosis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Thromboangiitis obliterans	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Thrombophlebitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Varicose ulceration	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Vasculitis	0.02% 1/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.00% 0/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Venous stenosis	0.00% 0/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	0.02% 1/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.

Other adverse events

Measure	Pemafibrate n=5264 participants at risk Participants receiving K-877 tablets administered twice daily.	Placebo n=5274 participants at risk Participants receiving Placebo matching tablet twice daily.
Gastrointestinal disorders Diarrhoea	5.9% 308/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	6.5% 343/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Urinary tract infection	7.9% 417/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	8.7% 461/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations COVID-19	6.9% 361/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	7.1% 377/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Nasopharyngitis	6.8% 358/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	6.7% 354/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Coronavirus infection	4.2% 221/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	5.0% 265/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Infections and infestations Influenza	4.8% 251/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	5.5% 290/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	14.0% 738/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	12.8% 677/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 417/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	8.6% 454/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.9% 311/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	6.7% 355/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Nervous system disorders Headache	4.3% 227/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	5.0% 265/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Renal and urinary disorders Diabetic nephropathy	6.8% 358/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	6.5% 343/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.
Vascular disorders Hypertension	13.0% 683/5264 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.	12.6% 664/5274 • From Baseline to a Median of 3.3 Years Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.

Additional Information

Director, Clinical Operations

Kowa Research Institute, Inc.

Phone: 1 (919) 433-1600

Email: CTGResults@KowaUS.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place