Trial Outcomes & Findings for Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) (NCT NCT05027074)

Last Updated: 2025-11-17

Results Overview

An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

506 participants

Primary outcome timeframe

From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 37 months

Results posted on

2025-11-17

Participant Flow

The participant with trial "Status Not Recorded" was discontinued from trial participation due to site termination of sponsor, but discontinuation form was not completed in the electronic data capture (EDC) in time by the terminated site.

Participant milestones

Participant milestones
Measure	MK-2060 20 mg MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Overall Study STARTED	171	167	168
Overall Study Treated	170	164	168
Overall Study COMPLETED	105	113	113
Overall Study NOT COMPLETED	66	54	55

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-2060 20 mg MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Overall Study Death	47	42	39
Overall Study Withdrawal by Parent/Guardian	1	0	0
Overall Study Site Terminated By Sponsor	3	0	2
Overall Study Withdrawal by Subject	13	8	10
Overall Study Lost to Follow-up	2	4	3
Overall Study Status Not Recorded	0	0	1

Baseline Characteristics

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-2060 20 mg n=171 Participants MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=167 Participants MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=168 Participants Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1	Total n=506 Participants Total of all reporting groups
Age, Continuous	62.2 Years STANDARD_DEVIATION 13.5 • n=202 Participants	58.8 Years STANDARD_DEVIATION 12.8 • n=283 Participants	60.5 Years STANDARD_DEVIATION 13.8 • n=120 Participants	60.5 Years STANDARD_DEVIATION 14.8 • n=122 Participants
Sex: Female, Male Female	97 Participants n=202 Participants	81 Participants n=283 Participants	83 Participants n=120 Participants	261 Participants n=122 Participants
Sex: Female, Male Male	74 Participants n=202 Participants	86 Participants n=283 Participants	85 Participants n=120 Participants	245 Participants n=122 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=202 Participants	67 Participants n=283 Participants	65 Participants n=120 Participants	209 Participants n=122 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	91 Participants n=202 Participants	98 Participants n=283 Participants	100 Participants n=120 Participants	289 Participants n=122 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=202 Participants	2 Participants n=283 Participants	3 Participants n=120 Participants	8 Participants n=122 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=202 Participants	1 Participants n=283 Participants	1 Participants n=120 Participants	4 Participants n=122 Participants
Race (NIH/OMB) Asian	6 Participants n=202 Participants	6 Participants n=283 Participants	4 Participants n=120 Participants	16 Participants n=122 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants	0 Participants n=283 Participants	2 Participants n=120 Participants	2 Participants n=122 Participants
Race (NIH/OMB) Black or African American	63 Participants n=202 Participants	73 Participants n=283 Participants	67 Participants n=120 Participants	203 Participants n=122 Participants
Race (NIH/OMB) White	99 Participants n=202 Participants	86 Participants n=283 Participants	94 Participants n=120 Participants	279 Participants n=122 Participants
Race (NIH/OMB) More than one race	1 Participants n=202 Participants	1 Participants n=283 Participants	0 Participants n=120 Participants	2 Participants n=122 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants	0 Participants n=122 Participants
Region US	118 Participants n=202 Participants	117 Participants n=283 Participants	118 Participants n=120 Participants	353 Participants n=122 Participants
Region non-US	53 Participants n=202 Participants	50 Participants n=283 Participants	50 Participants n=120 Participants	153 Participants n=122 Participants
Previous Thrombosis of Active Arteriovenous Graft (AVG) Yes	38 Participants n=202 Participants	35 Participants n=283 Participants	40 Participants n=120 Participants	113 Participants n=122 Participants
Previous Thrombosis of Active Arteriovenous Graft (AVG) No	133 Participants n=202 Participants	132 Participants n=283 Participants	128 Participants n=120 Participants	393 Participants n=122 Participants
Regular Aspirin Use up to 150 mg Daily at Baseline Yes	72 Participants n=202 Participants	69 Participants n=283 Participants	67 Participants n=120 Participants	208 Participants n=122 Participants
Regular Aspirin Use up to 150 mg Daily at Baseline No	99 Participants n=202 Participants	98 Participants n=283 Participants	101 Participants n=120 Participants	298 Participants n=122 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 37 months

Population: The analysis population consisted of all randomized participants, excluding three participants with arteriovenous fistula (AVF) rather than an AVG at randomization.

Outcome measures

Outcome measures
Measure	MK-2060 20 mg n=171 Participants MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=165 Participants MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=167 Participants Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Time to First Arteriovenous Graft (AVG) Thrombosis Event	23.80 events per 100 person-years	22.98 events per 100 person-years	30.17 events per 100 person-years

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: The analysis population consisted of all randomized participants, excluding three participants with AVF rather than an AVG at randomization.

An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent CAC adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

Outcome measures

Outcome measures
Measure	MK-2060 20 mg n=171 Participants MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=165 Participants MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=167 Participants Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Time to Each AVG Thrombosis Event (First and Recurrent)	38.95 events per 100 person-years	37.85 events per 100 person-years	42.97 events per 100 person-years

SECONDARY outcome

Timeframe: Up to approximately 40 months

Population: The analysis population consisted of all randomized participants who received at least one dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with one or more AEs is presented.

Outcome measures

Outcome measures
Measure	MK-2060 20 mg n=170 Participants MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=164 Participants MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=168 Participants Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Number of Participants Who Experience One or More Adverse Events (AEs)	161 Participants	143 Participants	155 Participants

SECONDARY outcome

Timeframe: From date of first dose of study intervention until the first ISTH major bleeding event or a clinically relevant non-major bleeding event. assessed up to approximately 40 months

Population: The analysis population consisted of all randomized participants who received at least one dose of study intervention.

Major bleeding events were defined as a having symptomatic presentation and including ≥1 of the following criteria: 1) Fatal bleeding 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome 3) Bleeding causing decrease in hematocrit level of 20 g/L or more or leading to transfusion of ≥2 units of whole blood or red cells. Clinically relevant non-major bleeding events were defined as signs or symptoms of hemorrhage that do not meet criteria for major bleeding events but meet ≥1 of the following criteria: 1) Requiring medical intervention by healthcare professional 2) Leading to hospitalization or increased level of care 3) Prompting face-to-face evaluation by healthcare professional. A time-to-event methodology was used. The incidence rate is presented.

Outcome measures

Outcome measures
Measure	MK-2060 20 mg n=170 Participants MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=164 Participants MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=168 Participants Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Time to First Event of International Society on Thrombosis (ISTH) Major Bleeding Event or a Clinically Relevant Non-Major Bleeding Event	24.73 events per 100 person-years	18.05 events per 100 person-years	14.04 events per 100 person-years

SECONDARY outcome

Timeframe: Up to approximately 37 months

Population: The analysis population consisted of all randomized participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	MK-2060 20 mg n=170 Participants MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=164 Participants MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=168 Participants Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Number of Participants Who Discontinue Study Intervention Due to an AE	47 Participants	32 Participants	46 Participants

Adverse Events

MK-2060 20 mg

Serious events: 110 serious events

Other events: 111 other events

Deaths: 50 deaths

MK-2060 6 mg

Serious events: 95 serious events

Other events: 106 other events

Deaths: 43 deaths

Placebo

Serious events: 112 serious events

Other events: 109 other events

Deaths: 41 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	MK-2060 20 mg n=170 participants at risk MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1	MK-2060 6 mg n=164 participants at risk MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1	Placebo n=168 participants at risk Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Gastrointestinal disorders Nausea	5.3% 9/170 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	1.8% 3/164 • Number of events 3 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	3.6% 6/168 • Number of events 6 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Blood and lymphatic system disorders Anaemia	6.5% 11/170 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	1.2% 2/164 • Number of events 4 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	3.6% 6/168 • Number of events 6 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Gastrointestinal disorders Abdominal pain	6.5% 11/170 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.7% 11/164 • Number of events 13 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	7.1% 12/168 • Number of events 13 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	6.5% 11/170 • Number of events 17 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	12.2% 20/164 • Number of events 26 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	5.4% 9/168 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Gastrointestinal disorders Vomiting	5.3% 9/170 • Number of events 9 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	3.7% 6/164 • Number of events 7 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.0% 10/168 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
General disorders Chest pain	5.9% 10/170 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.9% 8/164 • Number of events 8 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.0% 10/168 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
General disorders Puncture site haemorrhage	2.9% 5/170 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	5.5% 9/164 • Number of events 13 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	1.2% 2/168 • Number of events 5 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Infections and infestations COVID-19	7.6% 13/170 • Number of events 14 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.1% 10/164 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	10.7% 18/168 • Number of events 18 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Infections and infestations Urinary tract infection	5.9% 10/170 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.3% 7/164 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.8% 8/168 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Injury, poisoning and procedural complications Arteriovenous graft site haemorrhage	5.3% 9/170 • Number of events 24 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	9.8% 16/164 • Number of events 29 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.2% 7/168 • Number of events 8 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Injury, poisoning and procedural complications Arteriovenous graft site stenosis	12.9% 22/170 • Number of events 31 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	14.0% 23/164 • Number of events 51 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	13.7% 23/168 • Number of events 39 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	17.1% 29/170 • Number of events 54 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	21.3% 35/164 • Number of events 66 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	25.6% 43/168 • Number of events 86 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Injury, poisoning and procedural complications Fall	8.8% 15/170 • Number of events 15 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.7% 11/164 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	5.4% 9/168 • Number of events 18 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Metabolism and nutrition disorders Hyperkalaemia	3.5% 6/170 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.1% 10/164 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.5% 11/168 • Number of events 13 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 7/170 • Number of events 7 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	3.7% 6/164 • Number of events 7 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.0% 10/168 • Number of events 14 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	2.9% 5/170 • Number of events 5 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.3% 7/164 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	5.4% 9/168 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	8.8% 15/170 • Number of events 15 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	3.7% 6/164 • Number of events 6 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	5.4% 9/168 • Number of events 9 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Nervous system disorders Dizziness	4.7% 8/170 • Number of events 17 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	1.8% 3/164 • Number of events 4 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.0% 10/168 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Nervous system disorders Headache	5.3% 9/170 • Number of events 11 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.1% 10/164 • Number of events 13 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	8.3% 14/168 • Number of events 18 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	3.5% 6/170 • Number of events 6 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.9% 8/164 • Number of events 8 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.0% 10/168 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 4/170 • Number of events 4 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.9% 8/164 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	9.5% 16/168 • Number of events 26 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	6.5% 11/170 • Number of events 17 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	3.7% 6/164 • Number of events 8 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	2.4% 4/168 • Number of events 4 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Vascular disorders Hypertension	10.0% 17/170 • Number of events 20 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	5.5% 9/164 • Number of events 9 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	6.0% 10/168 • Number of events 21 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.
Vascular disorders Hypotension	7.1% 12/170 • Number of events 12 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	4.3% 7/164 • Number of events 10 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.	8.9% 15/168 • Number of events 32 • Up to approximately 40 months All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study intervention.