Trial Outcomes & Findings for Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes (NCT NCT02556203)

NCT ID: NCT02556203

Last Updated: 2020-01-13

Results Overview

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1653 participants
• Primary outcome timeframe: Through study completion, on average 14 months
• Results posted on: 2020-01-13

Participant Flow

Study was conducted at 136 centers world-wide between 16 Dec 2015 (first patient's first visit) and 27 Nov 2018 (last patient's last visit).

A total of 1674 subjects were screened, of which 1644 were randomly assigned to either of the two treatment arms and 1608 subjects started treatment with study medication.

Participant milestones

Measure	Rivaroxaban (Xarelto, BAY59-7939) Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Overall Study STARTED	826	818
Overall Study Received Treatment	801	807
Overall Study COMPLETED	799	792
Overall Study NOT COMPLETED	27	26

Reasons for withdrawal

Measure	Rivaroxaban (Xarelto, BAY59-7939) Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Overall Study Withdrawal by Subject	21	21
Overall Study Lost to Follow-up	5	5
Overall Study Adverse Event	1	0

Baseline Characteristics

Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes

Baseline characteristics by cohort

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.	Total n=1644 Participants Total of all reporting groups
Age, Continuous	80.38 Years STANDARD_DEVIATION 7.12 • n=5 Participants	80.77 Years STANDARD_DEVIATION 5.99 • n=7 Participants	80.57 Years STANDARD_DEVIATION 6.58 • n=5 Participants
Sex: Female, Male Female	400 Participants n=5 Participants	413 Participants n=7 Participants	813 Participants n=5 Participants
Sex: Female, Male Male	426 Participants n=5 Participants	405 Participants n=7 Participants	831 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	17 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	677 Participants n=5 Participants	694 Participants n=7 Participants	1371 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	123 Participants n=5 Participants	107 Participants n=7 Participants	230 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	692 Participants n=5 Participants	693 Participants n=7 Participants	1385 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	123 Participants n=5 Participants	115 Participants n=7 Participants	238 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, on average 14 months

Population: Safety analysis set (SAF): Included all randomized subjects who had been exposed to study drug at least once (1608 subjects overall).

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=801 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=807 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With Death or First Thromboembolic Event (DTE)	68 Participants	63 Participants

PRIMARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall)

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With Death or First Thromboembolic Event (DTE)	105 Participants	78 Participants

PRIMARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With Primary Bleeding Event (PBE)	46 Participants	31 Participants

SECONDARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With Net-clinical Benefit	137 Participants	100 Participants

SECONDARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With Cardiovascular Death or Thromboembolic Event	83 Participants	68 Participants

SECONDARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Composite of TIMI major and minor bleedings

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds	42 Participants	24 Participants

SECONDARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

ISTH major bleeds

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds	49 Participants	30 Participants

SECONDARY outcome

Timeframe: Through study completion, on average 16 months

Population: Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Composite of BARC 2,3 or 5 bleedings

Outcome measures

Measure	Rivaroxaban (Xarelto, BAY59-7939) n=826 Participants Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet n=818 Participants Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds	148 Participants	85 Participants

Adverse Events

Rivaroxaban Arm

Serious events: 296 serious events

Other events: 359 other events

Deaths: 70 deaths

Antiplatelet Arm

Serious events: 282 serious events

Other events: 302 other events

Deaths: 43 deaths

Serious adverse events

Measure	Rivaroxaban Arm n=801 participants at risk Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet Arm n=807 participants at risk Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Anaemia	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Anaemia macrocytic	0.12% 1/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Leukocytosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Polycythaemia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Thrombocytopenia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Angina pectoris	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Arrhythmia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrial fibrillation	2.1% 17/801 • Number of events 19 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	3.1% 25/807 • Number of events 27 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrial flutter	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrial tachycardia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrioventricular block	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrioventricular block complete	1.5% 12/801 • Number of events 12 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.9% 15/807 • Number of events 15 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrioventricular block first degree	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrioventricular block second degree	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Bradycardia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Bundle branch block left	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.74% 6/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac arrest	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure	2.0% 16/801 • Number of events 19 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.0% 16/807 • Number of events 22 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure acute	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure chronic	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure congestive	1.00% 8/801 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardio-respiratory arrest	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiovascular disorder	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Conduction disorder	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Coronary artery disease	0.62% 5/801 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Coronary artery stenosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Coronary ostial stenosis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Extrasystoles	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Left ventricular failure	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Mitral valve incompetence	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Myocardial ischaemia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Myocarditis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Palpitations	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Right ventricular failure	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Sinus arrest	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Sinus bradycardia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Supraventricular tachycardia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Tachycardia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Torsade de pointes	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Trifascicular block	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Ventricular arrhythmia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Ventricular extrasystoles	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Ventricular tachycardia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Coronary artery dissection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Bradyarrhythmia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiopulmonary failure	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Acute left ventricular failure	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiorenal syndrome	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Sinus node dysfunction	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Congenital, familial and genetic disorders Neuroacanthocytosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Ear and labyrinth disorders Vertigo	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Ear and labyrinth disorders Vertigo positional	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Endocrine disorders Primary adrenal insufficiency	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Blindness	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Cataract	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Keratitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Macular degeneration	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Retinal detachment	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Neovascular age-related macular degeneration	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Macular detachment	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Abdominal pain	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Abdominal pain upper	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Anal ulcer	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Colitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Constipation	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Diarrhoea	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Dysphagia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Enteritis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Enterocolitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Gastritis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Gastritis erosive	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Haemorrhoids	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Ileus	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Inguinal hernia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Intestinal ischaemia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Nausea	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Oesophageal obstruction	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Oesophagitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Pancreatitis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Umbilical hernia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Vomiting	0.25% 2/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Subileus	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Coeliac artery stenosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Asthenia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Chest pain	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Death	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Fatigue	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Gait disturbance	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Impaired healing	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Malaise	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Oedema peripheral	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Pain	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Pyrexia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Strangulated hernia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Sudden death	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Sudden cardiac death	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders General physical health deterioration	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Cardiac death	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Exercise tolerance decreased	0.12% 1/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Systemic inflammatory response syndrome	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Pacemaker generated arrhythmia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Inflammation	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Non-cardiac chest pain	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Multiple organ dysfunction syndrome	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Bile duct stone	0.37% 3/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Cholecystitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Cholecystitis acute	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Cholelithiasis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Hepatic cirrhosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Jaundice	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Immune system disorders Sarcoidosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Bacteraemia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Bronchitis	0.25% 2/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Cellulitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Clostridium difficile colitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Diverticulitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Endocarditis	1.00% 8/801 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.87% 7/807 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Endocarditis bacterial	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Endocarditis enterococcal	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Enterococcal bacteraemia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Erysipelas	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gangrene	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gastroenteritis	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gastroenteritis viral	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gastrointestinal infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Herpes zoster	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Infected skin ulcer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Infection	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Influenza	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Liver abscess	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Lower respiratory tract infection	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Orchitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Parotitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Peritonitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Pneumonia	2.9% 23/801 • Number of events 28 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.7% 22/807 • Number of events 23 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Pneumonia influenzal	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Postoperative wound infection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Pyelonephritis acute	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Sepsis	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Sialoadenitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Tooth abscess	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Tracheobronchitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Typhoid fever	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Urinary tract infection	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Viral infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Viral upper respiratory tract infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Wound infection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Urosepsis	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Groin infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Streptococcal bacteraemia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Pulmonary sepsis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Escherichia urinary tract infection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Arthritis bacterial	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Escherichia bacteraemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Staphylococcal sepsis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.25% 2/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Biliary sepsis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Abdominal sepsis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Wound abscess	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Renal cyst infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Intervertebral discitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Diabetic foot infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Lung infection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Streptococcal infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Peritonitis bacterial	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Respiratory tract infection viral	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Respiratory tract infection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Cardiac valve abscess	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Dermo-hypodermitis	0.12% 1/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Post procedural infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Septic encephalopathy	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Infective exacerbation of bronchiectasis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Streptococcal endocarditis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Medical device site joint infection	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Accident	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Clavicle fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Concussion	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Fall	1.5% 12/801 • Number of events 12 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Femoral neck fracture	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Femur fracture	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Hip fracture	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Humerus fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Joint dislocation	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Pancreatic injury	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Rib fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Stress fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Tendon rupture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Tibia fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Anaemia postoperative	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Traumatic fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Contusion	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Skin laceration	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Pelvic fracture	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Upper limb fracture	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Skin abrasion	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Periprosthetic fracture	0.12% 1/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Craniocerebral injury	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Skin wound	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Meniscus injury	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Coronary bypass stenosis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Arterial bypass stenosis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Post procedural hypoparathyroidism	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Product administration error	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Haemoglobin decreased	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Heart rate irregular	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Weight decreased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Ejection fraction decreased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Troponin increased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Inflammatory marker increased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Influenza A virus test positive	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Transvalvular pressure gradient increased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Dehydration	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Electrolyte imbalance	0.12% 1/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Gout	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Hypokalaemia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Hyponatraemia	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Back pain	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Bursitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.37% 3/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.2% 10/807 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Pain in extremity	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Pathological fracture	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid leukaemia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm malignant	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Axonal neuropathy	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Carotid artery stenosis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Carpal tunnel syndrome	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Dementia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Dementia Alzheimer's type	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Dizziness	1.1% 9/801 • Number of events 9 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Encephalopathy	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Epilepsy	0.25% 2/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Extrapyramidal disorder	0.12% 1/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Headache	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Hepatic encephalopathy	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Hypoglycaemic coma	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Hypotonia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Loss of consciousness	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Mental impairment	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Migraine	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Myasthenia gravis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Myelopathy	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Nerve compression	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Parkinsonism	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Petit mal epilepsy	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Presyncope	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Sciatica	0.50% 4/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Seizure	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Syncope	2.4% 19/801 • Number of events 20 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.9% 23/807 • Number of events 25 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Transient ischaemic attack	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Vertebrobasilar insufficiency	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders VIth nerve paralysis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Balance disorder	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Intercostal neuralgia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Vascular dementia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Ballismus	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Parkinson's disease	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Metabolic encephalopathy	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Brain injury	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Confusional state	0.25% 2/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Delirium	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Depression	0.25% 2/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Hallucination	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Panic disorder	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Suicide attempt	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Mental status changes	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Psychotic disorder	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Renal failure	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Urinary incontinence	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Urinary retention	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Renal impairment	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Chronic kidney disease	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Acute kidney injury	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.1% 17/807 • Number of events 17 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Reproductive system and breast disorders Ovarian cyst	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Reproductive system and breast disorders Rectocele	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Reproductive system and breast disorders Female genital tract fistula	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Aspiration	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.87% 7/801 • Number of events 9 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.87% 7/807 • Number of events 9 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Cough	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.74% 6/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Hiccups	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.62% 5/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Wheezing	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Pemphigus	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Diabetic foot	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Carotid endarterectomy	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Cochlea implant	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Hip arthroplasty	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Incisional hernia repair	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Knee arthroplasty	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Skin cyst excision	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Toe amputation	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Shoulder arthroplasty	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Hip surgery	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Peripheral artery angioplasty	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Cardiac resynchronisation therapy	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Cardiac ablation	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Dental operation	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Ear operation	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Eyelid operation	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Hernia repair	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Cardiac pacemaker adjustment	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Transcatheter arterial chemoembolisation	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Aortic dissection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Aortic stenosis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Circulatory collapse	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypertension	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypertensive crisis	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypotension	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypovolaemic shock	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Intermittent claudication	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Thrombophlebitis superficial	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Varicose vein	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Peripheral arterial occlusive disease	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.99% 8/807 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Product Issues Undersensing	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Product Issues Device battery issue	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.

Other adverse events

Measure	Rivaroxaban Arm n=801 participants at risk Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Antiplatelet Arm n=807 participants at risk Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
Blood and lymphatic system disorders Anaemia	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Iron deficiency anaemia	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Blood and lymphatic system disorders Splenomegaly	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Angina pectoris	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrial fibrillation	5.4% 43/801 • Number of events 44 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	5.5% 44/807 • Number of events 45 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrial flutter	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrial tachycardia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Atrioventricular block first degree	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.99% 8/807 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Bradycardia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Bundle branch block left	0.75% 6/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.87% 7/807 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure	1.7% 14/801 • Number of events 15 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.4% 11/807 • Number of events 11 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure chronic	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Cardiac failure congestive	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Left ventricular failure	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Mitral valve incompetence	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Palpitations	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Sinus bradycardia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Sinus tachycardia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Supraventricular tachycardia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Tachycardia	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Ventricular extrasystoles	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Ventricular tachycardia	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Left ventricular dysfunction	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Cardiac disorders Acute left ventricular failure	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Ear and labyrinth disorders Vertigo	2.1% 17/801 • Number of events 17 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.99% 8/807 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Ear and labyrinth disorders Vertigo positional	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Ear and labyrinth disorders Cerumen impaction	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Ear and labyrinth disorders Sudden hearing loss	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Endocrine disorders Hyperthyroidism	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Endocrine disorders Hypothyroidism	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.87% 7/807 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Cataract	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Lacrimation increased	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Vision blurred	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Eye disorders Visual impairment	0.75% 6/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Abdominal distension	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Abdominal pain	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Abdominal pain upper	1.00% 8/801 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.74% 6/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Constipation	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Diarrhoea	1.4% 11/801 • Number of events 12 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.1% 9/807 • Number of events 11 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Dyspepsia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Dysphagia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Gastritis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Nausea	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Toothache	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Gastrointestinal disorders Vomiting	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Asthenia	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Chest pain	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.5% 12/807 • Number of events 12 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Fatigue	1.6% 13/801 • Number of events 15 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.87% 7/807 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Gait disturbance	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Oedema	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Oedema peripheral	2.0% 16/801 • Number of events 16 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.5% 20/807 • Number of events 21 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Pyrexia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Peripheral swelling	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders General physical health deterioration	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Drug intolerance	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
General disorders Non-cardiac chest pain	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Immune system disorders Drug hypersensitivity	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Bronchitis	1.1% 9/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.5% 12/807 • Number of events 12 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Cellulitis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Conjunctivitis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Cystitis	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Erysipelas	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Fungal infection	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gastroenteritis	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gastrointestinal infection	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Gingivitis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Herpes zoster	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Infection	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Influenza	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Lower respiratory tract infection	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Nasopharyngitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Oesophageal candidiasis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Pneumonia	0.62% 5/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.2% 10/807 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Pulpitis dental	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Sinusitis	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Upper respiratory tract infection	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Urinary tract infection	3.7% 30/801 • Number of events 33 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.4% 19/807 • Number of events 21 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Infections and infestations Respiratory tract infection	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Fall	2.2% 18/801 • Number of events 18 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.0% 16/807 • Number of events 16 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Anaemia postoperative	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Contusion	1.4% 11/801 • Number of events 11 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.99% 8/807 • Number of events 11 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Skin laceration	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Injury, poisoning and procedural complications Skin abrasion	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Blood creatinine increased	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Blood glucose increased	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Blood pressure increased	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations C-reactive protein increased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Electrocardiogram QRS complex prolonged	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Glomerular filtration rate decreased	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Haemoglobin decreased	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations International normalised ratio abnormal	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Intraocular pressure increased	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Weight increased	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Ejection fraction decreased	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Investigations Transvalvular pressure gradient increased	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Dehydration	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Diabetes mellitus	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Gout	0.87% 7/801 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Hypokalaemia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Hyponatraemia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Vitamin D deficiency	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Metabolism and nutrition disorders Decreased appetite	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 9/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Arthritis	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Back pain	1.4% 11/801 • Number of events 12 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Groin pain	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Joint swelling	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Muscle spasms	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Muscular weakness	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Myalgia	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Neck pain	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Osteoporosis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Pain in extremity	0.87% 7/801 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.1% 9/807 • Number of events 9 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Amnesia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Carpal tunnel syndrome	0.25% 2/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Dementia	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Dementia Alzheimer's type	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Dizziness	4.0% 32/801 • Number of events 32 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	2.0% 16/807 • Number of events 16 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Headache	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.50% 4/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Hypoaesthesia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Presyncope	0.62% 5/801 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Sciatica	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Seizure	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Syncope	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.9% 15/807 • Number of events 16 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Nervous system disorders Cognitive disorder	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Anxiety	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Confusional state	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Depression	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Insomnia	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Psychiatric disorders Mental status changes	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Nocturia	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Renal failure	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Urinary retention	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Chronic kidney disease	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Renal and urinary disorders Acute kidney injury	0.75% 6/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.99% 8/807 • Number of events 8 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.00% 8/801 • Number of events 9 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.74% 6/807 • Number of events 7 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Cough	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.74% 6/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 17/801 • Number of events 17 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.74% 6/807 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Erythema	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Pruritus	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Rash	0.62% 5/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.62% 5/807 • Number of events 5 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.37% 3/807 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Skin ulcer	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Skin and subcutaneous tissue disorders Urticaria	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Tooth extraction	1.2% 10/801 • Number of events 10 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Surgical and medical procedures Cataract operation	0.75% 6/801 • Number of events 9 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Blood pressure fluctuation	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Haematoma	0.12% 1/801 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypertension	3.2% 26/801 • Number of events 26 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	3.5% 28/807 • Number of events 28 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypertensive crisis	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Hypotension	0.37% 3/801 • Number of events 3 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	1.2% 10/807 • Number of events 11 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Intermittent claudication	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Lymphoedema	0.50% 4/801 • Number of events 4 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Orthostatic hypotension	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.00% 0/807 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Peripheral vascular disorder	0.25% 2/801 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.12% 1/807 • Number of events 1 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Peripheral arterial occlusive disease	0.75% 6/801 • Number of events 6 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Vascular disorders Peripheral venous disease	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.
Product Issues Device dislocation	0.00% 0/801 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.	0.25% 2/807 • Number of events 2 • Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.

Additional Information

Therapeutic Area Head

Bayer

Phone: (+)1-888-84 22937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

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

Restriction type: GT60