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Clinical Trial Results:
EMPACT-MI: A streamlined, multicentre, randomised, parallel group, double-blind placebo-controlled superiority trial to evaluate the effect of EMPAgliflozin on hospitalisation for heart failure and mortality in patients with aCuTe Myocardial Infarction

Summary
EudraCT number	2019-001037-13
Trial protocol	DE HU PL NL BG FR DK ES
Global end of trial date	05 Nov 2023

Results information
Results version number	v1(current)
This version publication date	20 Nov 2024
First version publication date	20 Nov 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

1245-0202

ISRCTN number

-

US NCT number

NCT04509674

WHO universal trial number (UTN)

-

Sponsor organisation name

Boehringer Ingelheim

Sponsor organisation address

Binger Strasse 173, Ingelheim am Rhein, Germany, 55216

Public contact

Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com

Scientific contact

Boehringer Ingelheim, Call Center, Boehringer Ingelheim, 001 18002430127, clintriage.rdg@boehringer-ingelheim.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

29 Nov 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Nov 2023

Global end of trial reached?

Yes

Global end of trial date

05 Nov 2023

Was the trial ended prematurely?

No

Main objective of the trial

The main objective of this event-driven trial was to demonstrate the superiority of empagliflozin 10 mg once daily versus placebo, in addition to standard of care, for the reduction of the composite endpoint of time to first hospitalisation for heart failure (HHF) or all-cause mortality in high-risk patients hospitalised for acute myocardial infarction (MI).

Protection of trial subjects

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all subjects as required.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

16 Dec 2020

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 223

Country: Number of subjects enrolled

Australia: 41

Country: Number of subjects enrolled

Brazil: 359

Country: Number of subjects enrolled

Bulgaria: 422

Country: Number of subjects enrolled

Canada: 359

Country: Number of subjects enrolled

China: 215

Country: Number of subjects enrolled

Denmark: 42

Country: Number of subjects enrolled

France: 130

Country: Number of subjects enrolled

Germany: 234

Country: Number of subjects enrolled

Hungary: 253

Country: Number of subjects enrolled

India: 221

Country: Number of subjects enrolled

Israel: 403

Country: Number of subjects enrolled

Japan: 264

Country: Number of subjects enrolled

Korea, Republic of: 85

Country: Number of subjects enrolled

Netherlands: 229

Country: Number of subjects enrolled

Poland: 824

Country: Number of subjects enrolled

Romania: 868

Country: Number of subjects enrolled

Russian Federation: 112

Country: Number of subjects enrolled

Serbia: 379

Country: Number of subjects enrolled

Spain: 46

Country: Number of subjects enrolled

Ukraine: 373

Country: Number of subjects enrolled

United States: 528

Worldwide total number of subjects

6610

EEA total number of subjects

3048

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

3308

From 65 to 84 years

3189

85 years and over

113

Subject disposition

Top of page

Recruitment details

Randomised, placebo-controlled, double-blind, parallel-group trial in acute myocardial infarction (MI) hospitalised patients with high-risk for subsequent hospitalization for heart failure (HHF) and mortality. Patients were treated and remained in the trial until approximately a total number of 532 had primary endpoint events (i.e. event driven).

Screening details

All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site to ensured that they strictly met all inclusion and none of the exclusion criteria. One patient was randomised in error after death (i.e. mis-randomization) and was excluded from the randomised set.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Blinding implementation details

Patients, investigators, and everyone involved in trial conduct or analysis or with any other interest in this double-blind trial remained blinded to the randomised treatment assignments until after database lock.

Are arms mutually exclusive

Yes

Placebo

Arm description

Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Arm type

Placebo

Investigational medicinal product name

Placebo matching empagliflozin 10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Patients received, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Empagliflozin 10 mg

Arm description

Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Arm type

Experimental

Investigational medicinal product name

Empagliflozin

Investigational medicinal product code

Other name

Jardiance®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Patients received on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Number of subjects in period 1 ^[1]	Placebo	Empagliflozin 10 mg
Started	3262	3260
Treated	3229	3234
Completed	2513	2550
Not completed	749	710
Patient refusal to continue, not due to AE	452	418
Other reason than listed	106	95
Adverse event, serious fatal event	11	4
Lost to follow-up	31	39
Not treated	33	26
Protocol deviation	9	10
Adverse event, non-fatal event	107	118

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Out of the 6610 subjects enrolled, 6522 were randomised to a treatment.

Baseline characteristics

Top of page

Reporting group title

Placebo

Reporting group description

Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Reporting group title

Empagliflozin 10 mg

Reporting group description

Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Reporting group values	Placebo	Empagliflozin 10 mg	Total
Number of subjects	3262	3260	6522
Age categorical
Randomised set (RS): All randomised patients, whether treated or not.
Units: Patients
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	1623	1639	3262
From 65-84 years	1593	1556	3149
85 years and over	46	65	111
Age Continuous
Randomised set (RS): All randomised patients, whether treated or not.
Units: years
arithmetic mean (standard deviation)	63.7 ( 10.8 )	63.6 ( 11.0 )	-
Sex: Female, Male
Randomised set (RS): All randomised patients, whether treated or not.
Units: Patients
Female	813	812	1625
Male	2449	2448	4897
Race/Ethnicity, Customized
Randomised set (RS): All randomised patients, whether treated or not.
Units: Subjects
White	2721	2730	5451
Black/African-American	48	44	92
Asian	413	421	834
Other, including mixed race	7	9	16
Missing	73	56	129
Ethnicity (NIH/OMB)
Randomised set (RS): All randomised patients, whether treated or not.
Units: Subjects
Hispanic or Latino	331	338	669
Not Hispanic or Latino	2859	2866	5725
Unknown or Not Reported	72	56	128

End points

Top of page

Reporting group title

Placebo

Reporting group description

Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Reporting group title

Empagliflozin 10 mg

Reporting group description

Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Primary: Composite of time to first heart failure hospitalisation or all-cause mortality

Top of page

End point title

Composite of time to first heart failure hospitalisation or all-cause mortality

End point description

Incidence rate of the first occurrence of hospitalisation for heart failure (HHF) or death, whichever earliest, is reported. Median time-to-event was not estimable due to insufficient events being experienced. The incidence rate was calculated as: the number of patients with an event for hospitalization for heart failure or death by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient). The analysis was performed on the randomised set (RS) which contained all randomised patients, whether treated or not.

End point type

Primary

End point timeframe

From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

End point values	Placebo	Empagliflozin 10 mg
Number of subjects analysed	3262	3260
Units: Pt with events/100 pt-years at risk
number (confidence interval 95%)	6.58 (5.86 to 7.35)	5.85 (5.17 to 6.57)

Statistical analysis 1

Statistical analysis description

The primary endpoint was analysed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.

Comparison groups

Placebo v Empagliflozin 10 mg

Number of subjects included in analysis

6522

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.2061

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.06

Notes
[1] - Null hypothesis: there is no difference regarding the risk of the endpoint in question between empagliflozin and placebo. p<=0.05 required for testing of subsequent key secondary endpoint hypotheses Results are presented as Empagliflozin vs. Placebo.

Secondary: Key secondary endpoint - Total number of hospitalisations for heart failure (HHF) or all-cause mortality

Top of page

End point title

Key secondary endpoint - Total number of hospitalisations for heart failure (HHF) or all-cause mortality

End point description

The total number of hospitalisations for heart failure (HHF) or all-cause mortality is reported using the adjusted event rate. The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable. The analysis was performed on the randomised set (RS) which contained all randomised patients, whether treated or not.

End point type

Secondary

End point timeframe

From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

End point values	Placebo	Empagliflozin 10 mg
Number of subjects analysed	3262	3260
Units: Events/100 patient-years at risk
number (confidence interval 95%)	8.25 (6.92 to 9.83)	7.14 (5.91 to 8.63)

Statistical analysis 1

Statistical analysis description

The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Comparison groups

Placebo v Empagliflozin 10 mg

Number of subjects included in analysis

6522

Analysis specification

Pre-specified

Analysis type

other ^[2]

P-value

= 0.2423

Method

Negative binomial regression

Parameter type

Adjusted event rate ratio

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

1.1

Notes
[2] - Results are presented as Empagliflozin vs. Placebo.

Secondary: Key secondary endpoint - Total number of non-elective cardiovascular (CV) hospitalisations or all-cause mortality

Top of page

End point title

Key secondary endpoint - Total number of non-elective cardiovascular (CV) hospitalisations or all-cause mortality

End point description

The total number of non-elective cardiovascular (CV) hospitalisations or all-cause mortality is reported using the adjusted event rate. The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable. The analysis was performed on the randomised set (RS) which contained all randomised patients, whether treated or not.

End point type

Secondary

End point timeframe

From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

End point values	Placebo	Empagliflozin 10 mg
Number of subjects analysed	3262	3260
Units: Events/100 patient-years at risk
number (confidence interval 95%)	16.90 (15.10 to 18.92)	15.52 (13.82 to 17.43)

Statistical analysis 1

Statistical analysis description

The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Comparison groups

Placebo v Empagliflozin 10 mg

Number of subjects included in analysis

6522

Analysis specification

Pre-specified

Analysis type

other ^[3]

P-value

= 0.2867

Method

Negative binomial regression

Parameter type

Adjusted event rate ratio

Point estimate

0.92

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.07

Notes
[3] - Results are presented as Empagliflozin vs. Placebo.

Secondary: Key secondary endpoint - Total number of non-elective all-cause hospitalisations or all-cause mortality

Top of page

End point title

Key secondary endpoint - Total number of non-elective all-cause hospitalisations or all-cause mortality

End point description

The total number of non-elective all-cause hospitalisations or all-cause mortality is reported using the adjusted event rate. The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable. The analysis was performed on the randomised set (RS) which contained all randomised patients, whether treated or not.

End point type

Secondary

End point timeframe

From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

End point values	Placebo	Empagliflozin 10 mg
Number of subjects analysed	3262	3260
Units: Events/100 patient-years at risk
number (confidence interval 95%)	26.28 (23.92 to 28.87)	22.96 (20.84 to 25.31)

Statistical analysis 1

Statistical analysis description

The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Comparison groups

Placebo v Empagliflozin 10 mg

Number of subjects included in analysis

6522

Analysis specification

Pre-specified

Analysis type

other ^[4]

P-value

= 0.0463

Method

Negative binomial regression

Parameter type

Adjusted event rate ratio

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.7654

upper limit

0.9978

Notes
[4] - Results are presented as Empagliflozin vs. Placebo.

Secondary: Key secondary endpoint - Total number of hospitalisations for myocardial infarction (MI) or all-cause mortality

Top of page

End point title

Key secondary endpoint - Total number of hospitalisations for myocardial infarction (MI) or all-cause mortality

End point description

The total number of hospitalisations for myocardial infarction (MI) or all-cause mortality is reported using the adjusted event rate. The adjusted event rate is based on a negative binomial model adjusted for factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable. The analysis was performed on the randomised set (RS) which contained all randomised patients, whether treated or not.

End point type

Secondary

End point timeframe

From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

End point values	Placebo	Empagliflozin 10 mg
Number of subjects analysed	3262	3260
Units: Events/100 patient-years at risk
number (confidence interval 95%)	6.27 (5.19 to 7.58)	6.66 (5.49 to 8.08)

Statistical analysis 1

Statistical analysis description

The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Comparison groups

Placebo v Empagliflozin 10 mg

Number of subjects included in analysis

6522

Analysis specification

Pre-specified

Analysis type

other ^[5]

P-value

= 0.6311

Method

Negative binomial regression

Parameter type

Adjusted event rate ratio

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

1.35

Notes
[5] - Results are presented as Empagliflozin vs. Placebo.

Secondary: Time to cardiovascular (CV) mortality

Top of page

End point title

Time to cardiovascular (CV) mortality

End point description

Incidence rate of cardiovascular (CV) mortality, including deaths of unknown cause , is reported. Median time-to-event was not estimable due to insufficient events being experienced. The incidence rate was calculated as: the number of patients with a cardiovascular death event by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient). The analysis was performed on the randomised set (RS) which contained all randomised patients, whether treated or not.

End point type

Secondary

End point timeframe

From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

End point values	Placebo	Empagliflozin 10 mg
Number of subjects analysed	3262	3260
Units: Pt with events/100 pt-years at risk
number (confidence interval 95%)	2.76 (2.31 to 3.25)	2.78 (2.33 to 3.28)

Statistical analysis 1

Statistical analysis description

The statistical analysis was performed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.

Comparison groups

Placebo v Empagliflozin 10 mg

Number of subjects included in analysis

6522

Analysis specification

Pre-specified

Analysis type

other ^[6]

P-value

= 0.8124

Method

Regression, Cox

Parameter type

Hazard ratio (HR)

Point estimate

1.03

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.31

Notes
[6] - Results are presented as Empagliflozin vs. Placebo.

Adverse events

Top of page

Timeframe for reporting adverse events

From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days.

Adverse event reporting additional description

Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. In the randomised set, the deaths due to any cause were 178 in the Placebo group and 169 in the Empagliflozin group.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

Empagliflozin 10 mg

Reporting group description

Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Reporting group title

Placebo

Reporting group description

Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: There were no subjects affect with non-serious adverse events at a rate higher than 5%. The total number of no-serious adverse events is depicted in the initial table.

Serious adverse events	Empagliflozin 10 mg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	765 / 3234 (23.65%)	798 / 3229 (24.71%)
number of deaths (all causes)	165	175
number of deaths resulting from adverse events	137	140
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myeloid leukaemia
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	0 / 3234 (0.00%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
B-cell lymphoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of skin
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm malignant
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Keratoacanthoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac myxoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix cancer metastatic
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cervix carcinoma
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	4 / 3234 (0.12%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Colon neoplasm
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Essential thrombocythaemia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric cancer
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal carcinoma
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Breast cancer
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic gastric cancer
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung adenocarcinoma
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Lung squamous cell carcinoma recurrent
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm progression
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Mantle cell lymphoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Mesothelioma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to liver
subjects affected / exposed	1 / 3234 (0.03%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lung
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to pleura
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Laryngeal cancer
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic renal cell carcinoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Neoplasm prostate
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroendocrine carcinoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal neoplasm
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Penile squamous cell carcinoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal cancer
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	0 / 3234 (0.00%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmacytoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural neoplasm
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	6 / 3234 (0.19%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mucoepidermoid carcinoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	1 / 3234 (0.03%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin cancer
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer metastatic
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Soft tissue neoplasm
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer metastatic
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectosigmoid cancer stage III
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Arteriosclerosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute aortic syndrome
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	3 / 3234 (0.09%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic thrombosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arterial thrombosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure inadequately controlled
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Jugular vein thrombosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral artery embolism
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	3 / 3234 (0.09%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	7 / 3234 (0.22%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	8 / 3234 (0.25%)	7 / 3229 (0.22%)
occurrences causally related to treatment / all	0 / 8	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iliac artery arteriosclerosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral embolism
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vasoconstriction
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian artery stenosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subclavian vein stenosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Superficial vein thrombosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Surgical and medical procedures
Hospitalisation
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 3234 (0.00%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular stent thrombosis
subjects affected / exposed	3 / 3234 (0.09%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	9 / 3234 (0.28%)	12 / 3229 (0.37%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 1	0 / 0
Death
subjects affected / exposed	21 / 3234 (0.65%)	21 / 3229 (0.65%)
occurrences causally related to treatment / all	0 / 21	0 / 21
deaths causally related to treatment / all	0 / 21	0 / 21
Gait disturbance
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site haematoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	28 / 3234 (0.87%)	27 / 3229 (0.84%)
occurrences causally related to treatment / all	1 / 33	0 / 31
deaths causally related to treatment / all	0 / 2	0 / 0
Physical deconditioning
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	4 / 3234 (0.12%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden cardiac death
subjects affected / exposed	9 / 3234 (0.28%)	7 / 3229 (0.22%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 9	0 / 7
Sudden death
subjects affected / exposed	11 / 3234 (0.34%)	12 / 3229 (0.37%)
occurrences causally related to treatment / all	0 / 11	0 / 12
deaths causally related to treatment / all	0 / 11	0 / 12
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent stenosis
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac death
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Immune system disorders
Anaphylactic shock
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Social circumstances
Physical assault
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tobacco user
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Benign prostatic hyperplasia
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Penile scarring
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal haemorrhage
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	0 / 3234 (0.00%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Acute pulmonary oedema
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	6 / 3234 (0.19%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic obstructive pulmonary disease
subjects affected / exposed	4 / 3234 (0.12%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	4 / 3234 (0.12%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	1 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hiccups
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrothorax
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Idiopathic pulmonary fibrosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Obstructive sleep apnoea syndrome
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal fistula
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory acidosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary congestion
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	7 / 3234 (0.22%)	7 / 3229 (0.22%)
occurrences causally related to treatment / all	0 / 9	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary fibrosis
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	1 / 3234 (0.03%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 3234 (0.03%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Respiratory failure
subjects affected / exposed	5 / 3234 (0.15%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 5	1 / 5
deaths causally related to treatment / all	0 / 2	0 / 1
Sleep apnoea syndrome
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mania
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mental status changes
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Blood pressure increased
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium test positive
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
International normalised ratio increased
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stress echocardiogram abnormal
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Foot fracture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal injury
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic injury
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac procedure complication
subjects affected / exposed	3 / 3234 (0.09%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Craniofacial fracture
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis postoperative
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Face injury
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	2 / 3234 (0.06%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	1 / 3234 (0.03%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Procedural pneumothorax
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb traumatic amputation
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neck injury
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic fracture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax traumatic
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	9 / 3234 (0.28%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural stroke
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative delirium
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sternal fracture
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Strangulated incisional hernia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical procedure repeated
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Traumatic haematoma
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wrist fracture
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Atrial septal defect
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Buried penis syndrome
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Corneal dystrophy
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	5 / 3234 (0.15%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	30 / 3234 (0.93%)	28 / 3229 (0.87%)
occurrences causally related to treatment / all	0 / 32	0 / 29
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	52 / 3234 (1.61%)	54 / 3229 (1.67%)
occurrences causally related to treatment / all	1 / 57	0 / 58
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia supraventricular
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmic storm
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	18 / 3234 (0.56%)	17 / 3229 (0.53%)
occurrences causally related to treatment / all	0 / 19	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	6 / 3234 (0.19%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial tachycardia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial thrombosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	11 / 3234 (0.34%)	17 / 3229 (0.53%)
occurrences causally related to treatment / all	0 / 11	0 / 17
deaths causally related to treatment / all	0 / 9	0 / 11
Atrioventricular block complete
subjects affected / exposed	3 / 3234 (0.09%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Bradyarrhythmia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	2 / 3234 (0.06%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac aneurysm
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	159 / 3234 (4.92%)	230 / 3229 (7.12%)
occurrences causally related to treatment / all	1 / 194	2 / 306
deaths causally related to treatment / all	0 / 17	0 / 23
Cardiac perforation
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac ventricular disorder
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	11 / 3234 (0.34%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 12	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	6 / 3234 (0.19%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 6	0 / 5
deaths causally related to treatment / all	0 / 5	0 / 4
Coronary artery occlusion
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiovascular disorder
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic coronary syndrome
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	14 / 3234 (0.43%)	14 / 3229 (0.43%)
occurrences causally related to treatment / all	0 / 14	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 1
Coronary artery dissection
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery insufficiency
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiogenic shock
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	4 / 3234 (0.12%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery thrombosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dilated cardiomyopathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dressler's syndrome
subjects affected / exposed	3 / 3234 (0.09%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Interventricular septum rupture
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracardiac thrombus
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial rupture
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Microvascular coronary artery disease
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	110 / 3234 (3.40%)	94 / 3229 (2.91%)
occurrences causally related to treatment / all	0 / 119	0 / 104
deaths causally related to treatment / all	0 / 20	0 / 10
Myocardial injury
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 3234 (0.00%)	6 / 3229 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nodal rhythm
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricle rupture
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Papillary muscle rupture
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pericardial effusion
subjects affected / exposed	4 / 3234 (0.12%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pericarditis
subjects affected / exposed	3 / 3234 (0.09%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Postinfarction angina
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prinzmetal angina
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus arrest
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	1 / 3234 (0.03%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	3 / 3234 (0.09%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular extrasystoles
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular flutter
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	18 / 3234 (0.56%)	22 / 3229 (0.68%)
occurrences causally related to treatment / all	0 / 29	0 / 26
deaths causally related to treatment / all	0 / 0	0 / 1
Nervous system disorders
Cerebral hypoperfusion
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aphasia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery stenosis
subjects affected / exposed	4 / 3234 (0.12%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	1 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery thrombosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	6 / 3234 (0.19%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	1 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	8 / 3234 (0.25%)	8 / 3229 (0.25%)
occurrences causally related to treatment / all	0 / 8	0 / 8
deaths causally related to treatment / all	0 / 3	0 / 0
Cortical laminar necrosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial mass
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 3234 (0.00%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Headache
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	4 / 3234 (0.12%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	7 / 3234 (0.22%)	11 / 3229 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 2
Syncope
subjects affected / exposed	16 / 3234 (0.49%)	19 / 3229 (0.59%)
occurrences causally related to treatment / all	2 / 18	1 / 19
deaths causally related to treatment / all	0 / 0	0 / 1
Lumbar radiculopathy
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorder
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peroneal nerve palsy
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post-traumatic epilepsy
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 3234 (0.00%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ruptured cerebral aneurysm
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Seizure
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Lacunar infarction
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular encephalopathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral artery occlusion
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar insufficiency
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebrobasilar stroke
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	9 / 3234 (0.28%)	11 / 3229 (0.34%)
occurrences causally related to treatment / all	0 / 9	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemolysis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ear and labyrinth disorders
Sudden hearing loss
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Optic ischaemic neuropathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macular hole
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic retinopathy
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Macular degeneration
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery embolism
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal infarction
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vision blurred
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	3 / 3234 (0.09%)	5 / 3229 (0.15%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal polyp
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mechanical ileus
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	28 / 3234 (0.87%)	22 / 3229 (0.68%)
occurrences causally related to treatment / all	1 / 29	0 / 23
deaths causally related to treatment / all	0 / 1	0 / 1
Gastrointestinal necrosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	3 / 3234 (0.09%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal angina
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal metaplasia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Irritable bowel syndrome
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	3 / 3234 (0.09%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Melaena
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal stenosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oronasal fistula
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	3 / 3234 (0.09%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic floor hernia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric vein thrombosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 1
Cholangitis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic cholecystitis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cirrhosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver injury
subjects affected / exposed	6 / 3234 (0.19%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Portal vein thrombosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	2 / 3234 (0.06%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	4 / 3234 (0.12%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermatitis allergic
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Chronic kidney disease
subjects affected / exposed	1 / 3234 (0.03%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 1	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	27 / 3234 (0.83%)	43 / 3229 (1.33%)
occurrences causally related to treatment / all	6 / 32	8 / 51
deaths causally related to treatment / all	0 / 1	0 / 4
Bladder disorder
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	5 / 3234 (0.15%)	10 / 3229 (0.31%)
occurrences causally related to treatment / all	1 / 7	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephritis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	6 / 3234 (0.19%)	9 / 3229 (0.28%)
occurrences causally related to treatment / all	0 / 6	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Oliguria
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyuria
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal haematoma
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal impairment
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal infarct
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	1 / 3234 (0.03%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chondrocalcinosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mobility decreased
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 3234 (0.03%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oligoarthritis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	3 / 3234 (0.09%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronavirus infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	5 / 3234 (0.15%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
COVID-19
subjects affected / exposed	20 / 3234 (0.62%)	25 / 3229 (0.77%)
occurrences causally related to treatment / all	0 / 20	0 / 26
deaths causally related to treatment / all	0 / 3	0 / 4
COVID-19 pneumonia
subjects affected / exposed	14 / 3234 (0.43%)	10 / 3229 (0.31%)
occurrences causally related to treatment / all	0 / 14	0 / 10
deaths causally related to treatment / all	0 / 3	0 / 3
Campylobacter gastroenteritis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 3234 (0.00%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridial infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Colonic abscess
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complicated appendicitis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronavirus pneumonia
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dental fistula
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic gangrene
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea infectious
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	3 / 3234 (0.09%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endotoxic shock
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis infectious
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Enterocolitis bacterial
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Fungal infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perineal infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis aeromonas
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected fistula
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint abscess
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Norovirus infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ophthalmic herpes zoster
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal skin infection
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
SARS-CoV-2 viraemia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	9 / 3234 (0.28%)	8 / 3229 (0.25%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 0
Sepsis
subjects affected / exposed	2 / 3234 (0.06%)	3 / 3229 (0.09%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Septic shock
subjects affected / exposed	0 / 3234 (0.00%)	6 / 3229 (0.19%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 4
Staphylococcal bacteraemia
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tooth abscess
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	9 / 3234 (0.28%)	7 / 3229 (0.22%)
occurrences causally related to treatment / all	3 / 9	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	31 / 3234 (0.96%)	30 / 3229 (0.93%)
occurrences causally related to treatment / all	0 / 31	0 / 33
deaths causally related to treatment / all	0 / 4	0 / 3
Postoperative wound infection
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal abscess
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	2 / 3234 (0.06%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular neuronitis
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypovolaemia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cell death
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Decreased appetite
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	0 / 3234 (0.00%)	4 / 3229 (0.12%)
occurrences causally related to treatment / all	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	0 / 3234 (0.00%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	3 / 3234 (0.09%)	6 / 3229 (0.19%)
occurrences causally related to treatment / all	0 / 3	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	3 / 3234 (0.09%)	2 / 3229 (0.06%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ketoacidosis
subjects affected / exposed	2 / 3234 (0.06%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	1 / 3234 (0.03%)	0 / 3229 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polydipsia
subjects affected / exposed	0 / 3234 (0.00%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Type 1 diabetes mellitus
subjects affected / exposed	1 / 3234 (0.03%)	1 / 3229 (0.03%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Empagliflozin 10 mg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 3234 (0.00%)	0 / 3229 (0.00%)

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Were there any global substantial amendments to the protocol? Yes

20 Apr 2022

This amendment introduced mainly a major change regarding the increase in the number of randomised patients.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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