Trial Outcomes & Findings for Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications. (NCT NCT04218266)

NCT ID: NCT04218266

Last Updated: 2022-10-27

Results Overview

ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 755 participants
• Primary outcome timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)
• Results posted on: 2022-10-27

Participant Flow

Study was conducted at 94 centers in 14 countries or regions, between 30-Jan-2020 (first participant first visit) and 08-Oct-2021 (last participant last visit)

862 participants were screened. 107 participants were screening failures. 755 participants were randomized in a 1:1:1 ratio to 3 treatment groups: 251 participants to the asundexian 20 mg group, 254 participants to the asundexian 50 mg group and 250 participants to the apixaban group. 2 participants of asundexian 20 mg group never administered drug.

Participant milestones

Measure	Asundexian 20 mg Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Apixaban Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Overall Study STARTED	251	254	250
Overall Study Treated	249	254	250
Overall Study COMPLETED	226	227	218
Overall Study NOT COMPLETED	25	27	32

Reasons for withdrawal

Measure	Asundexian 20 mg Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Apixaban Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Overall Study Death	1	2	3
Overall Study Adverse Event	13	14	11
Overall Study Other	7	5	14
Overall Study Physician Decision	1	3	2
Overall Study Non-compliance with study drug	0	0	1
Overall Study Withdrawal by Subject	1	3	1
Overall Study Study drug never administered	2	0	0

Baseline Characteristics

Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.

Baseline characteristics by cohort

Measure	Asundexian 20 mg n=249 Participants Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg n=254 Participants Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Apixaban n=250 Participants Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks	Total n=753 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
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	43 Participants n=7 Participants	34 Participants n=5 Participants	110 Participants n=4 Participants
Age, Categorical >=65 years	216 Participants n=5 Participants	211 Participants n=7 Participants	216 Participants n=5 Participants	643 Participants n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	97 Participants n=7 Participants	109 Participants n=5 Participants	308 Participants n=4 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	157 Participants n=7 Participants	141 Participants n=5 Participants	445 Participants n=4 Participants
Race/Ethnicity, Customized Asian	39 Participants n=5 Participants	40 Participants n=7 Participants	40 Participants n=5 Participants	119 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized White	209 Participants n=5 Participants	212 Participants n=7 Participants	209 Participants n=5 Participants	630 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Population: Safety analysis set (SAF)

ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.

ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.

Outcome measures

Measure	Asundexian 20 mg n=249 Participants Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg n=254 Participants Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian Pooled n=503 Participants Asundexian 20 mg group and Asundexian 50 mg group	Apixaban n=250 Participants Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding or Clinically Relevant Non-major (CRNM) Bleeding	3 Participants	1 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Population: Safety analysis set (SAF)

Adjudication of all bleeding events was performed by members of the Clinical events committee (CEC) who reviewed events in a blinded fashion and adjudicated and classified the following events in a consistent and unbiased manner according to the following classifications: ISTH (major, clinically relevant non-major and minor); Thrombolysis in myocardial infarction (TIMI major, minor, requiring medical attention, minimal); Bleeding Academic Research Consortium (BARC type 1, 2, 3, 5).

Outcome measures

Measure	Asundexian 20 mg n=249 Participants Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg n=254 Participants Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian Pooled n=503 Participants Asundexian 20 mg group and Asundexian 50 mg group	Apixaban n=250 Participants Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Number of Participants With All Bleeding	12 Participants	10 Participants	22 Participants	26 Participants

SECONDARY outcome

Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Population: Safety analysis set (SAF)

ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of ≥ 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood.

Outcome measures

Measure	Asundexian 20 mg n=249 Participants Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg n=254 Participants Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian Pooled n=250 Participants Asundexian 20 mg group and Asundexian 50 mg group	Apixaban Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Number of Participants With ISTH Major Bleeding	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Population: Safety analysis set (SAF)

ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.

Outcome measures

Measure	Asundexian 20 mg n=249 Participants Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg n=254 Participants Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian Pooled n=503 Participants Asundexian 20 mg group and Asundexian 50 mg group	Apixaban n=250 Participants Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Number of Participants of ISTH Clinically Relevant Non-major (CRNM) Bleeding	3 Participants	1 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration)

Population: Safety analysis set (SAF)

All other overt bleeding episodes not meeting ISTH Major Bleeding criteria or clinically relevant non major bleeding were classified as minor bleeding.

Outcome measures

Measure	Asundexian 20 mg n=249 Participants Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Asundexian 50 mg n=254 Participants Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian Pooled n=503 Participants Asundexian 20 mg group and Asundexian 50 mg group	Apixaban n=250 Participants Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Number of Participants With ISTH Minor Bleeding	10 Participants	9 Participants	19 Participants	20 Participants

Adverse Events

Asundexian 50 mg

Serious events: 20 serious events

Other events: 116 other events

Deaths: 4 deaths

Asundexian 20 mg

Serious events: 22 serious events

Other events: 110 other events

Deaths: 2 deaths

Apixaban

Serious events: 20 serious events

Other events: 113 other events

Deaths: 5 deaths

Serious adverse events

Measure	Asundexian 50 mg n=254 participants at risk Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian 20 mg n=249 participants at risk Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Apixaban n=250 participants at risk Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Cardiac disorders Atrial fibrillation	1.2% 3/254 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Atrial flutter	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiac failure	1.6% 4/254 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiac failure acute	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiac failure chronic	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Coronary artery disease	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Myocardial infarction	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Palpitations	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Sinus arrest	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Ventricular tachycardia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Atrial thrombosis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Tachyarrhythmia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Sinus node dysfunction	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Colitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Dysphagia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Inguinal hernia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Nausea	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Chest pain	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Face oedema	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Sudden cardiac death	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Hepatobiliary disorders Drug-induced liver injury	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Cellulitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Erysipelas	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Herpes zoster	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Pyelonephritis acute	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Sepsis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Urinary tract infection	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations COVID-19 pneumonia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Ejection fraction decreased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Cerebrovascular accident	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Presyncope	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Seizure	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Peripheral sensorimotor neuropathy	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Anxiety	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Completed suicide	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Nephrolithiasis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Renal failure	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Renal impairment	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Acute kidney injury	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Surgical and medical procedures Cardiac ablation	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Surgical and medical procedures Percutaneous coronary intervention	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.

Other adverse events

Measure	Asundexian 50 mg n=254 participants at risk Participants received Asundexian (BAY2433334) 50 mg and Apixaban placebo for 12 weeks	Asundexian 20 mg n=249 participants at risk Participants received Asundexian (BAY2433334) 20 mg and Apixaban placebo for 12 weeks	Apixaban n=250 participants at risk Participants received Asundexian (BAY2433334) placebo and Apixaban for 12 weeks
Infections and infestations Gingival abscess	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Oral fungal infection	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Respiratory tract infection viral	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations COVID-19	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Accident	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Haematuria traumatic	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Sunburn	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Wrist fracture	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Contusion	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Inflammation of wound	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Lip injury	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Joint injury	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Tooth fracture	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Injury, poisoning and procedural complications Skin wound	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Amylase increased	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Aspartate aminotransferase increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood creatinine increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood glucose increased	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood potassium increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood pressure increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood thyroid stimulating hormone increased	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood urea increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Gamma-glutamyltransferase increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Haemoglobin decreased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Heart rate decreased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Lipase increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Lymphocyte count decreased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Neutrophil count increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Reticulocyte count decreased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Weight increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Urinary occult blood positive	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Blood alkaline phosphatase increased	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations Angiocardiogram	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Investigations SARS-CoV-2 test positive	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Dehydration	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Diabetes mellitus	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Fluid overload	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Gout	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.6% 4/249 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hyperglycaemia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hyperkalaemia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hyperuricaemia	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hypoglycaemia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Metabolism and nutrition disorders Hyperlipidaemia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 4/254 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.6% 4/249 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Joint swelling	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Muscle spasms	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Myalgia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Ageusia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Dizziness	3.1% 8/254 • Number of events 8 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	3.6% 9/249 • Number of events 9 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.8% 7/250 • Number of events 10 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Dysgeusia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Essential tremor	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Head discomfort	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Headache	2.8% 7/254 • Number of events 7 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.6% 4/249 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.0% 5/250 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Hypertonia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Hypoaesthesia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Neuritis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Paraesthesia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Parkinsonism	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Presyncope	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Sciatica	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Somnolence	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Syncope	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Tremor	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Nervous system disorders Orthostatic intolerance	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Anxiety	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Confusional state	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Delirium	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Depression	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Insomnia	0.79% 2/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Psychiatric disorders Nightmare	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Dysuria	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Haematuria	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.4% 6/250 • Number of events 6 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Hydronephrosis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Nocturia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Pollakiuria	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Renal colic	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Renal cyst	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Renal failure	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Urinary retention	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Renal impairment	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Chronic kidney disease	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Renal and urinary disorders Acute kidney injury	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Reproductive system and breast disorders Prostatitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 5/254 • Number of events 6 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Emphysema	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 5/254 • Number of events 8 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	4.4% 11/250 • Number of events 12 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Hiccups	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Productive cough	0.39% 1/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Pharyngeal paraesthesia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Blister	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Intertrigo	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Papule	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Pruritus	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.0% 5/249 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Rash	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Rash papular	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Surgical and medical procedures Cardioversion	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Surgical and medical procedures Tooth extraction	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Surgical and medical procedures Cataract operation	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Circulatory collapse	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Haematoma	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Hypertension	2.0% 5/254 • Number of events 6 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.4% 6/249 • Number of events 6 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.8% 7/250 • Number of events 7 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Hypotension	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Orthostatic hypotension	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Peripheral coldness	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Phlebitis superficial	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Subclavian artery thrombosis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Hypertensive urgency	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Vascular disorders Hot flush	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Blood and lymphatic system disorders Anaemia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Blood and lymphatic system disorders Spontaneous haematoma	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Angina pectoris	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Aortic valve stenosis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Arrhythmia supraventricular	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Atrial fibrillation	3.1% 8/254 • Number of events 9 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.8% 7/249 • Number of events 7 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.8% 7/250 • Number of events 7 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Atrial flutter	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Atrial tachycardia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Atrioventricular block first degree	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Bradycardia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiac failure	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.0% 5/250 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiac failure acute	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiac failure chronic	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Cardiomegaly	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Coronary artery disease	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Coronary artery stenosis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Myocardial ischaemia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Palpitations	1.6% 4/254 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Sinus bradycardia	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Sinus tachycardia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Tachycardia	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Cardiac disorders Ventricular tachycardia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Congenital, familial and genetic disorders Accessory spleen	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Ear and labyrinth disorders Tinnitus	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Ear and labyrinth disorders Vertigo	1.6% 4/254 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Ear and labyrinth disorders Vertigo labyrinthine	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Endocrine disorders Hyperthyroidism	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Endocrine disorders Hypothyroidism	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Conjunctival haemorrhage	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Dry eye	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Eye irritation	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Myopia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Photophobia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Swelling of eyelid	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Vision blurred	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Eye disorders Visual acuity reduced	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Abdominal discomfort	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Abdominal distension	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Abdominal pain upper	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.4% 6/250 • Number of events 6 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Change of bowel habit	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Constipation	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Dental caries	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Diarrhoea	4.3% 11/254 • Number of events 11 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.6% 4/249 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.0% 5/250 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Dry mouth	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Dyspepsia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Eructation	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Flatulence	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Food poisoning	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Gastritis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Gingival bleeding	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Haematochezia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Melaena	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Nausea	3.1% 8/254 • Number of events 8 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.4% 6/249 • Number of events 7 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	3.6% 9/250 • Number of events 10 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Oesophagitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Oral discomfort	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Saliva altered	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Stomatitis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Toothache	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Vomiting	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Large intestinal haemorrhage	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Gastrointestinal disorders Abdominal symptom	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Asthenia	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.6% 4/250 • Number of events 4 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Chest discomfort	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Chest pain	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Discomfort	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Fatigue	3.9% 10/254 • Number of events 10 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	2.0% 5/249 • Number of events 5 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Feeling abnormal	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Feeling cold	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Feeling hot	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Malaise	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Oedema	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Oedema peripheral	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Pain	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Pyrexia	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Thirst	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Peripheral swelling	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Hernia pain	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders General physical health deterioration	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Inflammation	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Adverse drug reaction	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Non-cardiac chest pain	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Vessel puncture site haematoma	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
General disorders Medical device site inflammation	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Hepatobiliary disorders Cholelithiasis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Hepatobiliary disorders Cholestasis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Hepatobiliary disorders Hepatic fibrosis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Hepatobiliary disorders Hepatomegaly	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Immune system disorders Amyloidosis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Bronchitis	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Cellulitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Cystitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Erysipelas	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Gastroenteritis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Gastroenteritis viral	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Gingivitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Herpes zoster	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/249 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Localised infection	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Lower respiratory tract infection	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/250 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Nasopharyngitis	1.2% 3/254 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Periodontitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Pharyngitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Pneumonia	0.79% 2/254 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Pulpitis dental	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Sinusitis	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Tinea cruris	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.40% 1/249 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Urinary tract infection	0.00% 0/254 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.80% 2/249 • Number of events 2 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	1.2% 3/250 • Number of events 3 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.
Infections and infestations Viral infection	0.39% 1/254 • Number of events 1 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/249 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 weeks.	0.00% 0/250 • After the first administration of study intervention with an average administration of 12 weeks (but not starting after more than 2 days after the last administration). Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of 14 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
• Publication restrictions are in place

Restriction type: OTHER