Trial Outcomes & Findings for Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack (NCT NCT04304534)

NCT ID: NCT04304534

Last Updated: 2023-04-05

Results Overview

CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. 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. ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1601 participants
• Primary outcome timeframe: From baseline up to 52 weeks
• Results posted on: 2023-04-05

Participant Flow

Study was conducted at 157 centers in 14 countries or regions, between 17-Jun-2020 (first participant first visit) and 21-Feb-2022 (last participant last visit)

1664 participants were screened, 63 participants were screening failures. 1601 participants were randomized in a 1:1:1:1 ratio to 4 treatment groups: 397, 401, and 402 participants to the asundexian 10 mg, 20 mg and 50 mg groups and 401 participants to the placebo group

Participant milestones

Measure	Asundexian 10 mg Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg Participants received Asundexian (BAY2433334) 50 mg	Placebo Participants received placebo
Overall Study STARTED	397	401	402	401
Overall Study Treated	395	397	402	399
Overall Study COMPLETED	303	317	309	309
Overall Study NOT COMPLETED	94	84	93	92

Reasons for withdrawal

Measure	Asundexian 10 mg Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg Participants received Asundexian (BAY2433334) 50 mg	Placebo Participants received placebo
Overall Study Subject decision COVID-19 pandemic related	1	0	1	0
Overall Study Non-Compliance with study drug	0	1	1	1
Overall Study Lost to Follow-up	0	1	2	3
Overall Study Unspecific	4	2	2	2
Overall Study Technical Problems	2	2	3	4
Overall Study Death	7	2	4	3
Overall Study Withdrawal by Subject	7	2	7	4
Overall Study Physician Decision	4	9	9	5
Overall Study Subject Decision	34	25	25	26
Overall Study Adverse Event	35	40	39	44

Baseline Characteristics

Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack

Baseline characteristics by cohort

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Total n=1601 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=5 Participants	123 Participants n=7 Participants	118 Participants n=5 Participants	136 Participants n=4 Participants	499 Participants n=21 Participants
Age, Categorical >=65 years	275 Participants n=5 Participants	278 Participants n=7 Participants	284 Participants n=5 Participants	265 Participants n=4 Participants	1102 Participants n=21 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	87 Participants n=7 Participants	100 Participants n=5 Participants	90 Participants n=4 Participants	370 Participants n=21 Participants
Sex: Female, Male Male	304 Participants n=5 Participants	314 Participants n=7 Participants	302 Participants n=5 Participants	311 Participants n=4 Participants	1231 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	53 Participants n=5 Participants	50 Participants n=7 Participants	50 Participants n=5 Participants	50 Participants n=4 Participants	203 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) White	334 Participants n=5 Participants	345 Participants n=7 Participants	347 Participants n=5 Participants	339 Participants n=4 Participants	1365 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	17 Participants n=21 Participants

PRIMARY outcome

Timeframe: From baseline up to 52 weeks

Population: FAS

CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.

Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.

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.

ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

Outcome measures

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)	27 Participants	24 Participants	22 Participants	22 Participants	—

PRIMARY outcome

Timeframe: From baseline up to 52 weeks

Population: SAF

Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.

Outcome measures

Measure	Asundexian 10 mg n=395 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=397 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=399 Participants Participants received placebo	Pooled Asundexian n=1194 Participants Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5	30 Participants	32 Participants	42 Participants	36 Participants	104 Participants

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: FAS

CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.

Outcome measures

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Efficacy - Number of Participants With CV Death	7 Participants	4 Participants	5 Participants	2 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: FAS

Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. 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

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Efficacy - Number of Participants With MI	18 Participants	20 Participants	18 Participants	17 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: FAS

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.

Outcome measures

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Efficacy - Number of Participants With Stroke	4 Participants	3 Participants	0 Participants	2 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: FAS

ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause

Outcome measures

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Efficacy - Number of Participants With Stent Thrombosis	4 Participants	5 Participants	4 Participants	4 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: FAS

Outcome measures

Measure	Asundexian 10 mg n=397 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=401 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=401 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Efficacy - Number of Participants With All Cause Mortality	10 Participants	7 Participants	10 Participants	7 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: SAF

All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention

Outcome measures

Measure	Asundexian 10 mg n=395 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=397 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=399 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Safety - Number of Participants With All Bleeding	70 Participants	75 Participants	82 Participants	85 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: SAF

Type 3a: 1) overt bleed + Hg drop of 3 to <5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.

Outcome measures

Measure	Asundexian 10 mg n=395 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=397 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=399 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Safety - Number of Participants With BARC Bleeding Definition Type 3, 5	5 Participants	3 Participants	3 Participants	5 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 52 weeks

Population: SAF

Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.

Outcome measures

Measure	Asundexian 10 mg n=395 Participants Participants received Asundexian (BAY2433334) 10 mg	Asundexian 20 mg n=397 Participants Participants received Asundexian (BAY2433334) 20 mg	Asundexian 50 mg n=402 Participants Participants received Asundexian (BAY2433334) 50 mg	Placebo n=399 Participants Participants received placebo	Pooled Asundexian Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group
Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5	70 Participants	75 Participants	82 Participants	85 Participants	—

Adverse Events

Asundexian 10 mg

Serious events: 74 serious events

Other events: 89 other events

Deaths: 10 deaths

Asundexian 20 mg

Serious events: 82 serious events

Other events: 118 other events

Deaths: 7 deaths

Asundexian 50 mg

Serious events: 67 serious events

Other events: 94 other events

Deaths: 10 deaths

Placebo

Serious events: 82 serious events

Other events: 107 other events

Deaths: 7 deaths

Serious adverse events

Measure	Asundexian 10 mg n=395 participants at risk Subjects received Asundexian (BAY2433334) 10 mg for 26 weeks at least and up to 52 weeks	Asundexian 20 mg n=397 participants at risk Subjects received Asundexian (BAY2433334) 20 mg for 26 weeks at least and up to 52 weeks	Asundexian 50 mg n=402 participants at risk Subjects received Asundexian (BAY2433334) 50 mg for 26 weeks at least and up to 52 weeks	Placebo n=399 participants at risk Subjects received Asundexian (BAY2433334) placebo for 26 weeks at least and up to 52 weeks
Blood and lymphatic system disorders Anaemia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Acute myocardial infarction	2.3% 9/395 • Number of events 9 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	2.3% 9/397 • Number of events 12 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	2.5% 10/402 • Number of events 11 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	2.0% 8/399 • Number of events 8 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Angina pectoris	1.3% 5/395 • Number of events 5 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.0% 4/397 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.5% 6/402 • Number of events 6 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Angina unstable	1.0% 4/395 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.0% 4/399 • Number of events 6 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Atrial fibrillation	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/399 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Atrioventricular block complete	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Atrioventricular block second degree	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac arrest	0.76% 3/395 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac failure	0.76% 3/395 • Number of events 5 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.0% 4/397 • Number of events 5 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.3% 5/399 • Number of events 6 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac failure acute	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac failure chronic	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac failure congestive	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac tamponade	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiogenic shock	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Coronary artery disease	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Coronary artery embolism	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Coronary artery stenosis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Coronary artery thrombosis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Dressler's syndrome	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Interventricular septum rupture	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Mitral valve incompetence	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Myocardial infarction	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.75% 3/402 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.75% 3/399 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Myocardial ischaemia	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Palpitations	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Pericardial effusion	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Supraventricular tachycardia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Ventricular fibrillation	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/399 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Ventricular tachycardia	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Intracardiac thrombus	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Coronary artery dissection	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiopulmonary failure	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Acute coronary syndrome	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.75% 3/399 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Coronary artery perforation	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Stress cardiomyopathy	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Cardiac disorders Sinus node dysfunction	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Ear and labyrinth disorders Vertigo	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Colitis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Diarrhoea	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Gastritis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Haematemesis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Haematochezia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Melaena	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Pancreatitis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Proctalgia	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Rectal haemorrhage	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Rectal ulcer haemorrhage	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Mechanical ileus	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Gastric antral vascular ectasia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Gastrointestinal disorders Large intestine polyp	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Asthenia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Chest discomfort	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Chest pain	1.0% 4/395 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.3% 5/397 • Number of events 5 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.00% 4/402 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.0% 4/399 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Death	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Malaise	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Pyrexia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Inflammation	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Non-cardiac chest pain	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Vascular stent thrombosis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/399 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Vascular stent stenosis	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/399 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Bile duct stone	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Cholecystitis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Hepatobiliary disorders Portal hypertension	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Appendicitis	0.76% 3/395 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Cystitis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Diverticulitis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Diverticulitis intestinal haemorrhagic	0.25% 1/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Erysipelas	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Gastroenteritis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Pneumonia	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Pneumonia aspiration	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Sepsis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Urinary tract infection	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Urinary tract infection bacterial	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Clostridium difficile infection	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Respiratory tract infection	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations Acarodermatitis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations COVID-19	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.7% 7/402 • Number of events 7 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.3% 5/399 • Number of events 5 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Infections and infestations COVID-19 pneumonia	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	1.0% 4/399 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Head injury	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Road traffic accident	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Contusion	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Urinary retention postoperative	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Investigations Coagulation factor VIII level increased	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Investigations Haemoglobin decreased	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Investigations Arterial bruit	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Investigations Hepatic enzyme increased	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Investigations Von Willebrand's factor antigen increased	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Investigations Von Willebrand's factor activity increased	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Metabolism and nutrition disorders Hyperkalaemia	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Altered state of consciousness	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Ataxia	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Cerebral haemorrhage	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Cerebral infarction	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Cerebrovascular accident	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Dizziness	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Dizziness postural	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Myelitis transverse	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Sciatica	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Syncope	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Transient ischaemic attack	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Spinal epidural haematoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Ischaemic cerebral infarction	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Ischaemic stroke	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Metabolic encephalopathy	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Haematuria	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Nephrolithiasis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Renal artery stenosis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Renal colic	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Urinary retention	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Renal impairment	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Acute kidney injury	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/402 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Renal and urinary disorders Ureterolithiasis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Reproductive system and breast disorders Prostatitis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Reproductive system and breast disorders Uterine polyp	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/399 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.75% 3/399 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 4 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/397 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.50% 2/399 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.51% 2/395 • Number of events 2 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Skin and subcutaneous tissue disorders Diabetic foot	0.51% 2/395 • Number of events 3 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Coronary arterial stent insertion	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Transurethral bladder resection	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Polypectomy	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Sigmoidectomy	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Cardiac resynchronisation therapy	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Percutaneous coronary intervention	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Surgical and medical procedures Revascularisation procedure	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Aortic stenosis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Arterial rupture	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Giant cell arteritis	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Haematoma	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Hypertension	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/397 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/399 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Shock	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Vascular stenosis	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Hypertensive urgency	0.25% 1/395 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/402 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/395 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/397 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.25% 1/402 • Number of events 1 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	0.00% 0/399 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.

Other adverse events

Measure	Asundexian 10 mg n=395 participants at risk Subjects received Asundexian (BAY2433334) 10 mg for 26 weeks at least and up to 52 weeks	Asundexian 20 mg n=397 participants at risk Subjects received Asundexian (BAY2433334) 20 mg for 26 weeks at least and up to 52 weeks	Asundexian 50 mg n=402 participants at risk Subjects received Asundexian (BAY2433334) 50 mg for 26 weeks at least and up to 52 weeks	Placebo n=399 participants at risk Subjects received Asundexian (BAY2433334) placebo for 26 weeks at least and up to 52 weeks
Gastrointestinal disorders Diarrhoea	5.6% 22/395 • Number of events 23 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.3% 21/397 • Number of events 22 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.5% 22/402 • Number of events 25 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	4.5% 18/399 • Number of events 19 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
General disorders Chest pain	3.3% 13/395 • Number of events 15 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	7.3% 29/397 • Number of events 32 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	3.7% 15/402 • Number of events 15 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	4.3% 17/399 • Number of events 20 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Nervous system disorders Dizziness	4.6% 18/395 • Number of events 19 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	4.8% 19/397 • Number of events 22 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.2% 21/402 • Number of events 22 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	4.8% 19/399 • Number of events 22 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.3% 21/395 • Number of events 21 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	6.8% 27/397 • Number of events 28 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.2% 21/402 • Number of events 23 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.8% 23/399 • Number of events 25 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.3% 17/395 • Number of events 25 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	4.8% 19/397 • Number of events 45 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.2% 21/402 • Number of events 29 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	5.0% 20/399 • Number of events 26 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.
Vascular disorders Hypertension	5.6% 22/395 • Number of events 23 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	6.8% 27/397 • Number of events 29 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	3.7% 15/402 • Number of events 15 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.	7.5% 30/399 • Number of events 30 • After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.

Additional Information

Therapeutic Area Head

Bayer AG

Phone: (+) 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contracts Partners shall ensure that all patentable Results made by employees of Center or other parties involved by Contract Partners in connection with the performance of the Study, will be notified to Bayer without delay.
• Publication restrictions are in place

Restriction type: OTHER