Trial Outcomes & Findings for A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke (NCT NCT05643573)

NCT ID: NCT05643573

Last Updated: 2024-12-09

Results Overview

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (this does not include myocardial infarction, thromboembolism of the pulmonary vasculature or venous thrombosis, e.g. pulmonary embolism or deep venous thrombosis).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

14830 participants

Primary outcome timeframe

Approximately 12 months

Results posted on

2024-12-09

Participant Flow

Study was conducted at 1035 study centers across in Asia, Europe, North America, South America, and Australia, between 05-Dec-2022 (first participant first visit) and 31-Jan-2024 (last participant last visit).

A total of 16436 participants were screened, of whom 1606 participants were screen failures. 14830 of the screened participants were randomized to treatment and 14757 participants were treated. 73 participants never received study intervention.

Participant milestones

Participant milestones
Measure	Asundexian Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Overall Study STARTED	7383	7374
Overall Study COMPLETED	6901	7012
Overall Study NOT COMPLETED	482	362

Reasons for withdrawal

Reasons for withdrawal
Measure	Asundexian Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Overall Study Adverse Event	117	90
Overall Study Death	53	57
Overall Study Lost to Follow-up	6	3
Overall Study Other	18	15
Overall Study Outcome event	64	36
Overall Study Physician Decision	33	19
Overall Study Protocol-specified withdrawal criterion met	2	2
Overall Study Site terminated by sponsor	10	10
Overall Study Study terminated by sponsor	1	0
Overall Study Withdrawal by Subject	178	130

Baseline Characteristics

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.	Total n=14810 Participants Total of all reporting groups
Age, Continuous	73.9 Years STANDARD_DEVIATION 7.7 • n=5 Participants	73.9 Years STANDARD_DEVIATION 7.7 • n=7 Participants	73.9 Years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	2656 Participants n=5 Participants	2558 Participants n=7 Participants	5214 Participants n=5 Participants
Sex: Female, Male Male	4759 Participants n=5 Participants	4837 Participants n=7 Participants	9596 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	533 Participants n=5 Participants	507 Participants n=7 Participants	1040 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6774 Participants n=5 Participants	6793 Participants n=7 Participants	13567 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	108 Participants n=5 Participants	95 Participants n=7 Participants	203 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	2035 Participants n=5 Participants	2010 Participants n=7 Participants	4045 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Black or African American	88 Participants n=5 Participants	95 Participants n=7 Participants	183 Participants n=5 Participants
Race (NIH/OMB) White	5216 Participants n=5 Participants	5211 Participants n=7 Participants	10427 Participants n=5 Participants
Race (NIH/OMB) More than one race	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 12 months

Population: aFAS

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (this does not include myocardial infarction, thromboembolism of the pulmonary vasculature or venous thrombosis, e.g. pulmonary embolism or deep venous thrombosis).

Outcome measures

Outcome measures
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of Stroke or Systemic Embolism	98 Participants	26 Participants

PRIMARY outcome

Timeframe: Approximately 12 months

Population: Safety Analysis Set (SAF): All participants randomized to study intervention and who took at least 1 dose of study intervention. N=14757 Adjusted Safety Analysis Set (aSAF): All participants in the Safety Analysis Set excluding subjects randomized from one site in Japan. N=14737 Due to Good Clinical Practice violations, 20 participants from one site in Japan were excluded from all analyses. aSAF population was analyzed for this outcome measure.

Assessment based on the (csHR), comparing asundexian with apixaban which is based on time to first event. ISTH Major Bleeding was defined as an event that meets at least one of the below criteria, based on the definition given by the ISTH (Schulman and Kearon 2005): * Fatal bleeding, and/or * Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular with compromised vision, pericardial, retroperitoneal, intra-articular, or intramuscular with compartment syndrome), and/or * Clinically overt\* bleeding associated with a recent (within 48 hours) decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared with the most recent hemoglobin value available before the event, and/or * Clinically overt\* bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. * Overt bleeding required the identification of the bleeding location and the hemoglobin drop and/or transfusion needed to be related to the bleeding.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding	17 Participants	53 Participants

PRIMARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of Stroke, Systemic Embolism, or ISTH Major Bleeding	120 Participants	75 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aFAS

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. An ischemic stroke was defined as the rapid onset (or present on awakening) of a new focal neurological deficit with clinical (\> 24 hours symptoms / signs) or imaging evidence of infarction that is not attributable to a non-ischemic cause (i.e. not associated with infection, tumor, seizure, severe metabolic disease).

Outcome measures

Outcome measures
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of Ischemic Stroke or Systemic Embolism	96 Participants	22 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aFAS

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.

Outcome measures

Outcome measures
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With All-cause Mortality	60 Participants	71 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aFAS

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. An ischemic stroke was defined as the rapid onset (or present on awakening) of a new focal neurological deficit with clinical (\> 24 hours symptoms / signs) or imaging evidence of infarction that is not attributable to a non-ischemic cause (i.e. not associated with infection, tumor, seizure, severe metabolic disease).

Outcome measures

Outcome measures
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Ischemic Stroke	85 Participants	21 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aFAS

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. CV death included death due to stroke, myocardial infarction, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes or CV procedures. In addition, death due to non-traumatic cardiovascular hemorrhage will be included, e.g. non-stroke intracranial hemorrhage, non-procedural or non-traumatic vascular rupture (e.g. aortic aneurysm), or hemorrhage causing cardiac tamponade

Outcome measures

Outcome measures
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Cardiovascular (CV) Death	48 Participants	44 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aFAS

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. The diagnosis of MI requires the combination of: * Presence of acute myocardial injury (changes in cardiac biomarkers) and * Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post mortem pathological findings irrespective of biomarker values.

Outcome measures

Outcome measures
Measure	Asundexian n=7415 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7395 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of CV Death, Stroke, or Myocardial Infarction (MI)	155 Participants	77 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. Clinically relevant non-major bleeding was considered any sign or symptom of acute or sub-acute clinically overt bleeding that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria (based on criteria published by the EMA) (EMA 2014): * requiring medical or surgical treatment by a healthcare professional for bleeding * leading to hospitalization or increased level of care for bleeding * a change in antithrombotic therapy (including study intervention) for bleeding \*Overt bleeding required the identification of the bleeding location.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of ISTH Major or Clinically Relevant Non-major Bleeding	83 Participants	188 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Clinically Relevant Non-major Bleeding	67 Participants	140 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. Hemorrhagic stroke was defined as an acute, atraumatic extravasation of blood into the brain parenchyma, intraventricular or subarachnoid space with associated neurological symptoms. This does not include microbleeds or hemorrhagic transformation of an ischemic stroke.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Hemorrhagic Stroke	1 Participants	6 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Intracranial Hemorrhage	3 Participants	18 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Fatal Bleeding	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. All other overt bleeding episodes not meeting the criteria for ISTH major or clinically relevant non-major bleeding were classified as minor bleeding (for example, bleeding from a minor wound that does not prompt a treatment for the bleeding, for instance with surgical hemostasis, or epistaxis that does not require a medical treatment for bleeding or a change in antithrombotic therapy).

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Minor Bleeding	187 Participants	317 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of Stroke, Systemic Embolism, ISTH Major Bleeding, or All-cause Mortality	149 Participants	101 Participants

SECONDARY outcome

Timeframe: Approximately 12 months

Population: aSAF

The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event. Critical bleeding was defined as symptomatic bleeding in either of the following critical locations (intracranial, intraspinal, pericardial, intra-articular, or retroperitoneal) or as intraocular bleeding with compromised vision or intramuscular bleeding with compartment syndrome.

Outcome measures

Outcome measures
Measure	Asundexian n=7373 Participants Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 Participants Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Number of Participants With Composite of Disabling Stroke (mRS ≥ 3), Critical Bleeding, or All-cause Mortality	51 Participants	56 Participants

Adverse Events

Asundexian

Serious events: 582 serious events

Other events: 467 other events

Deaths: 73 deaths

Apixaban

Serious events: 599 serious events

Other events: 455 other events

Deaths: 85 deaths

Serious adverse events

Serious adverse events
Measure	Asundexian n=7373 participants at risk Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 participants at risk Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Infections and infestations Diverticulitis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Endocarditis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Erysipelas	0.03% 2/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Gangrene	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Gastroenteritis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Gastroenteritis clostridial	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Gastroenteritis viral	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Hepatitis E	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Anaemia	0.07% 5/7373 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Leukocytosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Microcytic anaemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Thrombocytopenia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Nephrogenic anaemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Blood and lymphatic system disorders Immune thrombocytopenia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Angina pectoris	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Aortic valve stenosis	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Arrhythmia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Arteriosclerosis coronary artery	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrial fibrillation	0.64% 47/7373 • Number of events 50 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.96% 71/7364 • Number of events 84 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrial flutter	0.11% 8/7373 • Number of events 8 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrial tachycardia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrioventricular block	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrioventricular block complete	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrioventricular block second degree	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Bradycardia	0.08% 6/7373 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.11% 8/7364 • Number of events 9 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiac arrest	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiac failure	0.73% 54/7373 • Number of events 55 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.84% 62/7364 • Number of events 78 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiac failure acute	0.24% 18/7373 • Number of events 23 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.34% 25/7364 • Number of events 28 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiac failure chronic	0.24% 18/7373 • Number of events 18 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.11% 8/7364 • Number of events 8 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiac failure congestive	0.14% 10/7373 • Number of events 13 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.19% 14/7364 • Number of events 15 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiogenic shock	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiovascular disorder	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cor pulmonale	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Coronary artery disease	0.08% 6/7373 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Coronary artery stenosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Left ventricular failure	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Low cardiac output syndrome	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Mitral valve incompetence	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Myocardial ischaemia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Nodal arrhythmia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Nodal rhythm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Palpitations	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Pericarditis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Right ventricular failure	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Sinoatrial block	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Sinus arrest	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Sinus bradycardia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Supraventricular tachycardia	0.03% 2/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Tachycardia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Ventricular arrhythmia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Ventricular fibrillation	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Ventricular tachycardia	0.08% 6/7373 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Intracardiac thrombus	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Atrial thrombosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Tachyarrhythmia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Bradyarrhythmia	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Dilated cardiomyopathy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiac valve disease	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Acute left ventricular failure	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Arrhythmic storm	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Cardiorenal syndrome	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Sinus node dysfunction	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Cardiac disorders Chronic coronary syndrome	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Ear and labyrinth disorders Vertigo	0.05% 4/7373 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Ear and labyrinth disorders Vertigo labyrinthine	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Ear and labyrinth disorders Vertigo positional	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Ear and labyrinth disorders Inner ear disorder	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Endocrine disorders Goitre	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Endocrine disorders Hyperparathyroidism primary	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Endocrine disorders Hyperthyroidism	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Endocrine disorders Thyrotoxic crisis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Endocrine disorders Thyroid mass	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Cataract	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Eyelid ptosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Pseudopapilloedema	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Retinal detachment	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Visual acuity reduced	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Epiretinal membrane	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Eye disorders Rhegmatogenous retinal detachment	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Abdominal mass	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Abdominal pain	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Abdominal pain upper	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Chronic gastritis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Colitis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Colitis ischaemic	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Constipation	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Diarrhoea	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Dyspepsia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Enterocolitis	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Gastritis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.08% 6/7364 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Haematochezia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Haemorrhoids	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Hiatus hernia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Ileal stenosis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Ileus	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Incarcerated inguinal hernia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Inguinal hernia	0.08% 6/7373 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Intestinal ischaemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Intestinal perforation	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Melaena	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Nausea	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Pancreatitis acute	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Small intestinal obstruction	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Umbilical hernia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Vomiting	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Large intestine polyp	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Oedematous pancreatitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Epiploic appendagitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Abdominal wall haematoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Asthenia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Chest discomfort	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Chest pain	0.15% 11/7373 • Number of events 11 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.15% 11/7364 • Number of events 11 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Chills	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Death	0.08% 6/7373 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Gait disturbance	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Mass	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Oedema	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Oedema peripheral	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Pain	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Pyrexia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Sudden death	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Peripheral swelling	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Sudden cardiac death	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders General physical health deterioration	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Systemic inflammatory response syndrome	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Gait deviation	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Non-cardiac chest pain	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Medical device site haematoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Multiple organ dysfunction syndrome	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
General disorders Procedural failure	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Bile duct stone	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Cholangitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Cholangitis acute	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Cholecystitis	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Cholecystitis acute	0.07% 5/7373 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Cholelithiasis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Hepatic failure	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Hepatitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Liver injury	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Hepatobiliary disorders Congestive hepatopathy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Immune system disorders Anaphylactic reaction	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Immune system disorders Hypersensitivity	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Abscess oral	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Appendicitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Bacteraemia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Bronchitis	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Cellulitis	0.12% 9/7373 • Number of events 10 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Clostridium difficile colitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Cryptosporidiosis infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Cystitis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Cystitis escherichia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Influenza	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Localised infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Lower respiratory tract infection	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Meningitis listeria	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Nosocomial infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Orchitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Osteomyelitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Otitis externa	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Peritonitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pneumonia	0.30% 22/7373 • Number of events 22 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.38% 28/7364 • Number of events 34 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pneumonia aspiration	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pneumonia viral	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pulmonary tuberculosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pyelonephritis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pyelonephritis acute	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pyelonephritis chronic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Sepsis	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Septic shock	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Skin infection	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Tooth abscess	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Tracheobronchitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Urinary tract infection	0.09% 7/7373 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.18% 13/7364 • Number of events 14 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Vestibular neuronitis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Viral infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Viral upper respiratory tract infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Wound infection	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Urosepsis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Rectal abscess	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Scrotal abscess	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Abscess soft tissue	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Haematoma infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pulmonary sepsis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Perineal abscess	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Arthritis bacterial	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Escherichia bacteraemia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Abdominal infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.03% 2/7373 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Biliary sepsis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Abdominal sepsis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Enteritis infectious	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Diabetic foot infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Pneumonia bacterial	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Respiratory syncytial virus infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Parainfluenzae virus infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Soft tissue infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Respiratory tract infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Enterocolitis bacterial	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Chikungunya virus infection	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Medical device site infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Infected bite	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Bullous erysipelas	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations COVID-19	0.09% 7/7373 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.14% 10/7364 • Number of events 10 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations COVID-19 pneumonia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Klebsiella urinary tract infection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Accident	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Ankle fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Concussion	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Fall	0.07% 5/7373 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Femoral neck fracture	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Femur fracture	0.12% 9/7373 • Number of events 9 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Forearm fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Fracture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Fractured sacrum	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Head injury	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Hip fracture	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Humerus fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Joint dislocation	0.03% 2/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Multiple fractures	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Multiple injuries	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Patella fracture	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Rib fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Spinal compression fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Spinal fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Sternal fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Tibia fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Wound	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Post procedural bile leak	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Skin laceration	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Joint injury	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Limb injury	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Upper limb fracture	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Limb crushing injury	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Post procedural haematuria	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Toxicity to various agents	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Procedural pneumothorax	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Injury, poisoning and procedural complications Craniofacial fracture	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Blood potassium increased	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Colonoscopy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Endoscopy upper gastrointestinal tract	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Blood urine present	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Heart rate increased	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Brain natriuretic peptide increased	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Transaminases increased	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Scan myocardial perfusion abnormal	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Clostridium test positive	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations Liver function test increased	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Investigations SARS-CoV-2 test positive	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Dehydration	0.07% 5/7373 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Diabetes mellitus	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Hyperkalaemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Hypervolaemia	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Hypoglycaemia	0.04% 3/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Hypokalaemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Hyponatraemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Arthritis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Arthropathy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Back pain	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Bursitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.12% 9/7373 • Number of events 9 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.08% 6/7364 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Osteoporosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Pain in extremity	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Still's disease	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Vertebral lateral recess stenosis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Musculoskeletal and connective tissue disorders Meniscopathy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chordoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer recurrent	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage IV	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum neoplasm	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 2/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine neoplasm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extramammary Paget's disease	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix adenoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) High-grade B-cell lymphoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bing-Neel syndrome	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Altered state of consciousness	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Carotid artery stenosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Cerebral circulatory failure	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Cerebral haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Cerebral infarction	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Dementia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Dementia Alzheimer's type	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Dizziness	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Dysarthria	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Epilepsy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Generalised tonic-clonic seizure	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Haemorrhage intracranial	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Haemorrhagic stroke	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Headache	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Hepatic encephalopathy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Hypoaesthesia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Loss of consciousness	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Migraine	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Motor neurone disease	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Parkinsonism	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Presyncope	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Sciatica	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Seizure	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Spinal cord compression	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Syncope	0.14% 10/7373 • Number of events 11 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.16% 12/7364 • Number of events 13 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Tremor	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Trigeminal neuralgia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Vertebrobasilar insufficiency	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders VIth nerve paralysis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Cervical radiculopathy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Lumbar radiculopathy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Haemorrhagic transformation stroke	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Putamen haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Parkinson's disease	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Carotid artery disease	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Metabolic encephalopathy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Cerebral microhaemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Postresuscitation encephalopathy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Cervicogenic vertigo	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Post stroke epilepsy	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Intracranial mass	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Confusional state	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Depression	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Panic attack	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Suicidal ideation	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Suicide attempt	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Mental status changes	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Major depression	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Psychiatric disorders Neuropsychological symptoms	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Dysuria	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Haematuria	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Nephrolithiasis	0.07% 5/7373 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Nephropathy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Nephrotic syndrome	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Renal failure	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Urinary retention	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Urinary tract disorder	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Diabetic nephropathy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Renal impairment	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Chronic kidney disease	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Nephritic syndrome	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Renal and urinary disorders Acute kidney injury	0.35% 26/7373 • Number of events 26 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.16% 12/7364 • Number of events 12 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Reproductive system and breast disorders Breast mass	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Reproductive system and breast disorders Prostatitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.04% 3/7373 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.11% 8/7373 • Number of events 8 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 7 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.15% 11/7373 • Number of events 11 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.15% 11/7364 • Number of events 11 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.15% 11/7373 • Number of events 11 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.05% 4/7364 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 5 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Cough variant asthma	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Rash	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Skin ulcer	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Skin ulcer haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Diabetic foot	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.03% 2/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Social circumstances Abstains from alcohol	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Aortic stenosis	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Haematoma	0.03% 2/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Hypertension	0.05% 4/7373 • Number of events 4 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.07% 5/7364 • Number of events 6 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Hypertensive crisis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Hypotension	0.04% 3/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Thrombophlebitis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Subclavian vein thrombosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Shock haemorrhagic	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Deep vein thrombosis	0.01% 1/7373 • Number of events 2 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Iliac artery stenosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Haemorrhage	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Hypertensive emergency	0.01% 1/7373 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Hypoperfusion	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Extremity necrosis	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Aortic rupture	0.00% 0/7373 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.01% 1/7364 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Peripheral arterial occlusive disease	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.04% 3/7364 • Number of events 3 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Peripheral artery stenosis	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Vascular disorders Vein dissection	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Product Issues Device malfunction	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Product Issues Device dislocation	0.01% 1/7373 • Number of events 1 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.00% 0/7364 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.

Other adverse events

Other adverse events
Measure	Asundexian n=7373 participants at risk Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo.	Apixaban n=7364 participants at risk Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo.
Gastrointestinal disorders Diarrhoea	1.6% 115/7373 • Number of events 124 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	0.98% 72/7364 • Number of events 73 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations Nasopharyngitis	1.3% 98/7373 • Number of events 104 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	1.2% 89/7364 • Number of events 92 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Infections and infestations COVID-19	1.3% 97/7373 • Number of events 99 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	1.5% 109/7364 • Number of events 109 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Nervous system disorders Dizziness	1.8% 132/7373 • Number of events 138 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	1.5% 113/7364 • Number of events 120 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.68% 50/7373 • Number of events 59 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.	1.3% 96/7364 • Number of events 120 • Approximately 12 months AEs that occurred or worsened after the first dose of study intervention up to 2 days after the last dose of study intervention are considered treatment-emergent. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact.

Additional Information

Therapeutic Area Head

Bayer AG

Phone: (+)1-888-84 22937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER