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Clinical Trial Results:
A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients with Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial)

Summary
EudraCT number	2011-004726-10
Trial protocol	NL PL
Global end of trial date	31 May 2018

Results information
Results version number	v1(current)
This version publication date	01 Mar 2022
First version publication date	01 Mar 2022
Other versions

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

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Trial information

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Sponsor protocol code

AMR-01-01-0019

ISRCTN number

US NCT number

NCT01492361

WHO universal trial number (UTN)

Sponsor organisation name

Amarin Pharma, Inc.

Sponsor organisation address

440 Route 22 Suite 300, Bridgewater, United States, 08807

Public contact

Alex Giaquinto, Amarin Pharma, Inc., +1 908719-1315, alex.giaquinto@amarincorp.com

Scientific contact

Alex Giaquinto, Amarin Pharma, Inc., +1 908719-1315, alex.giaquinto@amarincorp.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

24 Sep 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

31 May 2018

Global end of trial reached?

Yes

Global end of trial date

31 May 2018

Was the trial ended prematurely?

Main objective of the trial

The primary objective is, in patients at low-density lipoprotein cholesterol (LDL-C) goal while on statin therapy, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting triglycerides [TG] ≥200 mg/dL and <500 mg/dL [≥2.26 mmol/L and <5.64 mmol/L]), to evaluate the effect of 4 g/day AMR101 on the time from randomization to first occurrence of any component of the composite of the following major cardiovascular (CV) events: • CV death; • Nonfatal myocardial infarction (MI), (including silent MI; electrocardiograms [ECGs] will be performed annually for the detection of silent MIs); • Nonfatal stroke; • Coronary revascularization; or • Unstable angina determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

Protection of trial subjects

A data monitoring committee (DMC) was instituted for REDUCE-IT to ensure ongoing patient safety and to oversee and review the pre-specified interim analyses. Recommendations for study continuation at the interim analyses were guided by an interim decision-making process pre-specified in the interim statistical analysis plan; formal efficacy analyses were performed as well as safety evaluations at all safety data reviews. The DMC was specifically charged with monitoring the event rates in the active and placebo groups to assess any possible contribution of the placebo selection to the results. Members of the DMC did not otherwise participate in the study. The committee included two cardiologists (electrophysiologists) and one independent statistician, along with a second supporting, but non-voting independent statistician.

Background therapy

Stable dose of low, moderate, or high intensity statin (± ezetimibe) for at least 4 weeks prior to screening

Evidence for comparator

Actual start date of recruitment

21 Nov 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 189

Country: Number of subjects enrolled

Canada: 250

Country: Number of subjects enrolled

India: 262

Country: Number of subjects enrolled

New Zealand: 134

Country: Number of subjects enrolled

Romania: 202

Country: Number of subjects enrolled

Russian Federation: 709

Country: Number of subjects enrolled

Ukraine: 836

Country: Number of subjects enrolled

United States: 3146

Country: Number of subjects enrolled

South Africa: 414

Country: Number of subjects enrolled

Netherlands: 1678

Country: Number of subjects enrolled

Poland: 359

Worldwide total number of subjects

8179

EEA total number of subjects

2239

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

4416

From 65 to 84 years

3734

85 years and over

Subject disposition

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Recruitment details

473 sites enrolled or followed patients in 11 countries (United States, the Netherlands, Ukraine, Russian Federation, South Africa, Poland, India, Canada, Romania, Australia, and New Zealand). The first patient was screened in November 2011 and the last patient was randomized in August 2016.

Screening details

Screened Subjects: 19,212; Reason for Screen Fail: Incl./Excl. criteria not met, 10,429; Withdrawal of Consent, 340; Adverse Event, 13; CV Risk Category 2 Closed, 4; Lost to Follow-up, 108; Death, 5, Enrollment closed, 3; Other, 135. (4 patients presented 2 screen failure reasons)

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Assessor

Blinding implementation details

Treatment was assigned using a computer-generated randomization scheme via Interactive Web Response System. Study medication and placebo were similar in appearance. Patients, investigators, Sponsor, study administrators, and support staff were blinded. Sponsor data analysts were blinded.

Are arms mutually exclusive

Yes

AMR101

Arm description

4 1-g icosapent ethyl capsules daily (2 capsules BID)

Arm type

Experimental

Investigational medicinal product name

icosapent ethyl

Investigational medicinal product code

AMR101

Other name

ethyl-EPA, Ethyl-Eicosapentaenoate, Vazkepa, Vascepa

Pharmaceutical forms

Capsule, soft

Routes of administration

Oral use

Dosage and administration details

4 g/day administered as 4 1-g capsules taken orally, 2 capsules BID, with food

Placebo

Arm description

matching placebo

Arm type

Placebo

Investigational medicinal product name

placebo

Investigational medicinal product code

Other name

matching placebo

Pharmaceutical forms

Capsule, soft

Routes of administration

Oral use

Dosage and administration details

4 g BID

Number of subjects in period 1	AMR101	Placebo
Started	4089	4090
Death before the final visit	265 ^[1]	295 ^[2]
Completed	3684	3630
Not completed	405	460
Consent withdrawn by subject	281	297
Investigator judgement	12	12
Other	49	62
Incomplete final visit	63	89

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of death before the final visit is the actual value from the study
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of death before the final visit is the actual value from the study

Baseline characteristics

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Reporting group title

AMR101

Reporting group description

4 1-g icosapent ethyl capsules daily (2 capsules BID)

Reporting group title

Placebo

Reporting group description

matching placebo

Reporting group values	AMR101	Placebo	Total
Number of subjects	4089	4090	8179
Age categorical
Units: Subjects
Adults (18-64 years)	2232	2184	4416
From 65-84 years	1846	1888	3734
85 years and over	11	18	29
Age continuous
Men and women ≥45 years of age with established CVD, or ≥50 years of age with diabetes in combination with ≥1 additional risk factor for CVD were eligible for enrollment
Units: years
median (inter-quartile range (Q1-Q3))	64.0 (57.0 to 69.0)	64.0 (57.0 to 69.0)	-
Gender categorical
Units: Subjects
Female	1162	1195	2357
Male	2927	2895	5822
Cardiovascular risk stratum
CV Risk Category 1 (Secondary Prevention Cohort): patients with established CVD defined in the inclusion criteria CV Risk Category 2 (Primary Prevention Cohort): patients with diabetes and at least one additional risk factor for CVD, but no established CVD
Units: Subjects
Secondary Prevention Cohort	2892	2893	5785
Primary Prevention Cohort	1197	1197	2394

Subject analysis set title

Intent-to-Treat population

Subject analysis set type

Intention-to-treat

Subject analysis set description

The Intent-to-Treat (ITT) population was defined as all patients who were randomized via the IWRS. The Safety population was the same as the ITT population.

Subject analysis sets values	Intent-to-Treat population
Number of subjects	8179
Age categorical
Units: Subjects
Adults (18-64 years)	4416
From 65-84 years	3734
85 years and over	29
Age continuous
Men and women ≥45 years of age with established CVD, or ≥50 years of age with diabetes in combination with ≥1 additional risk factor for CVD were eligible for enrollment
Units: years
median (inter-quartile range (Q1-Q3))	64.0 (57.0 to 69.0)
Gender categorical
Units: Subjects
Female	2357
Male	5822
Cardiovascular risk stratum
CV Risk Category 1 (Secondary Prevention Cohort): patients with established CVD defined in the inclusion criteria CV Risk Category 2 (Primary Prevention Cohort): patients with diabetes and at least one additional risk factor for CVD, but no established CVD
Units: Subjects
Secondary Prevention Cohort	5785
Primary Prevention Cohort	2394

End points

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Reporting group title

AMR101

Reporting group description

4 1-g icosapent ethyl capsules daily (2 capsules BID)

Reporting group title

Placebo

Reporting group description

matching placebo

Subject analysis set title

Intent-to-Treat population

Subject analysis set type

Intention-to-treat

Subject analysis set description

The Intent-to-Treat (ITT) population was defined as all patients who were randomized via the IWRS. The Safety population was the same as the ITT population.

Primary: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, and Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization

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End point title

Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, and Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization

End point description

Time from randomization to the first occurrence of any component of the composite of the following clinical events: CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, and unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization.

End point type

Primary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	705	901

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region

Comparison groups

Placebo v AMR101

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

< 0.00001 ^[2]

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

0.83

Notes
[1] - The purpose of this study is to evaluate whether AMR101, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term clinical events in patients with mixed dyslipidemia at high risk for cardiovascular (CV) events.
[2] - The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O’Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.

Secondary: Composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke.

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End point title

Composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke.

End point description

Key secondary outcome measure is the time from randomization to the first occurrence of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke.

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	459	606

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.00001 ^[3]

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.74

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

0.83

Notes
[3] - Because the primary endpoint was statistically significant, prespecified secondary end points were tested in a hierarchical fashion, in the order listed below, at the final alpha level of 0.0437.

Secondary: Composite of CV Death or Nonfatal MI (Including Silent MI).

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End point title

Composite of CV Death or Nonfatal MI (Including Silent MI).

End point description

Time from randomization to the first occurrence of the composite of CV death or nonfatal MI (including silent MI).

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	392	507

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

0.86

Secondary: Fatal or Nonfatal MI (Including Silent MI).

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End point title

Fatal or Nonfatal MI (Including Silent MI).

End point description

Time from randomization to the first occurrence of fatal or nonfatal MI (including silent MI).

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	250	355

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

0.81

Secondary: Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

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End point title

Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

End point description

Time from randomization to the first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications.

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	216	321

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.65

Confidence interval

level

95%

sides

2-sided

lower limit

0.55

upper limit

0.78

Secondary: CV Death

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End point title

CV Death

End point description

Time from randomization to the occurrence of CV death

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	174	213

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0315

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

0.98

Secondary: Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

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End point title

Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

End point description

Time from randomization to the first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization.

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	108	157

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0018

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.68

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

0.87

Secondary: Fatal or Nonfatal Stroke.

Top of page

End point title

Fatal or Nonfatal Stroke.

End point description

Time from randomization to the first occurrence of fatal or nonfatal stroke.

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	98	134

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0129

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.55

upper limit

0.93

Secondary: Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

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End point title

Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

End point description

Time from randomization to the first occurrence of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke.

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	549	690

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

0.69

upper limit

0.86

Secondary: Total Mortality.

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End point title

Total Mortality.

End point description

Time from randomization to the first occurrence of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke.

End point type

Secondary

End point timeframe

4-6 years

End point values	AMR101	Placebo
Number of subjects analysed	4089	4090
Units: Subjects	274	310

Log-rank test & Cox proportional model

Statistical analysis description

Stratified by CV risk category, use of ezetimibe, and geographical region.

Comparison groups

AMR101 v Placebo

Number of subjects included in analysis

8179

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0915

Method

Log-rank test & Cox proportional model

Parameter type

Hazard ratio (HR)

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

1.02

Adverse events

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Timeframe for reporting adverse events

4-6 years

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.1

Reporting group title

AMR101

Reporting group description

Reporting group title

Placebo

Reporting group description

Serious adverse events	AMR101	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	1252 / 4089 (30.62%)	1254 / 4090 (30.66%)
number of deaths (all causes)	274	310
number of deaths resulting from adverse events	94	102
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
Adenocarcinoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma gastric
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Adenocarcinoma of colon
subjects affected / exposed	6 / 4089 (0.15%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 2
Adenoid cystic carcinoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal adenoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Adrenal neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anal cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal squamous cell carcinoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
B-cell lymphoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Benign neoplasm of thyroid gland
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	8 / 4089 (0.20%)	9 / 4090 (0.22%)
occurrences causally related to treatment / all	1 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 1
Bladder cancer recurrent
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder cancer stage III
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neoplasm
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder transitional cell carcinoma
subjects affected / exposed	5 / 4089 (0.12%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Bone cancer
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain neoplasm
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Breast cancer
subjects affected / exposed	14 / 4089 (0.34%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 15	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer male
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer metastatic
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Breast cancer recurrent
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Breast cancer stage I
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cancer pain
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Central nervous system neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cervix carcinoma
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Cervix neoplasm
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangiocarcinoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholesteatoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clear cell renal cell carcinoma
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colon adenoma
subjects affected / exposed	1 / 4089 (0.02%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	10 / 4089 (0.24%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 10	0 / 6
deaths causally related to treatment / all	0 / 1	0 / 0
Colon cancer metastatic
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Colon cancer recurrent
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colon neoplasm
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal adenocarcinoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colorectal cancer
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Colorectal cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diffuse large B-cell lymphoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Endometrial adenocarcinoma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Endometrial cancer
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial cancer stage I
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extranodal marginal zone B-cell lymphoma (MALT type)
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric adenoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	4 / 4089 (0.10%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 1
Gastric cancer recurrent
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastric neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stromal tumour
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal tract adenoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic cancer
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatocellular carcinoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Iris melanoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large cell lung cancer metastatic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Large intestine benign neoplasm
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngeal cancer
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Leiomyosarcoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lipoma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	4 / 4089 (0.10%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Lung adenocarcinoma stage II
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Lung adenocarcinoma stage IV
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lung cancer metastatic
subjects affected / exposed	8 / 4089 (0.20%)	9 / 4090 (0.22%)
occurrences causally related to treatment / all	0 / 9	0 / 9
deaths causally related to treatment / all	0 / 7	0 / 7
Lung carcinoma cell type unspecified recurrent
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lung neoplasm malignant
subjects affected / exposed	8 / 4089 (0.20%)	14 / 4090 (0.34%)
occurrences causally related to treatment / all	0 / 9	0 / 14
deaths causally related to treatment / all	0 / 3	0 / 5
Lymphocytic leukaemia
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant glioma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	7 / 4089 (0.17%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Malignant melanoma in situ
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant mesenteric neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meningioma
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to abdominal cavity
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to bone
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to central nervous system
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Metastases to chest wall
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to kidney
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to liver
subjects affected / exposed	4 / 4089 (0.10%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	1 / 4	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Metastases to lung
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to lymph nodes
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to peritoneum
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Metastasis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic carcinoma of the bladder
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic gastric cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Metastatic neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metastatic squamous cell carcinoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Mucinous adenocarcinoma of appendix
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mucoepidermoid carcinoma of salivary gland
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myelodysplastic syndrome
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nasal neoplasm
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Neuroendocrine carcinoma of the skin
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neuroma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nodular melanoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 2
Non-small cell lung cancer metastatic
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer stage III
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer stage IV
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Oesophageal cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal carcinoma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Oesophageal neoplasm
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oropharyngeal cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian adenoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ovarian epithelial cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian epithelial cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Ovarian granulosa-theca cell tumour
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic carcinoma
subjects affected / exposed	6 / 4089 (0.15%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 4	0 / 4
Pancreatic carcinoma metastatic
subjects affected / exposed	5 / 4089 (0.12%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Pancreatic neoplasm
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parathyroid tumour benign
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Penile cancer
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pituitary tumour
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Pleural mesothelioma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Prostate cancer
subjects affected / exposed	26 / 4089 (0.64%)	26 / 4090 (0.64%)
occurrences causally related to treatment / all	0 / 27	1 / 26
deaths causally related to treatment / all	0 / 1	0 / 1
Prostate cancer metastatic
subjects affected / exposed	5 / 4089 (0.12%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 1
Prostate cancer recurrent
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer stage IV
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic adenoma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal adenocarcinoma
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal cancer
subjects affected / exposed	2 / 4089 (0.05%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 1
Rectal neoplasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Refractory anaemia with ringed sideroblasts
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Refractory cytopenia with unilineage dysplasia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cancer
subjects affected / exposed	6 / 4089 (0.15%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 2	0 / 0
Renal cancer metastatic
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Renal cell carcinoma
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal neoplasm
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal cancer
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Salivary gland adenoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schwannoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Small cell lung cancer metastatic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestine carcinoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	4 / 4089 (0.10%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of lung
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 2	0 / 0
Squamous cell carcinoma of pharynx
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Testis cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Throat cancer
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid cancer metastatic
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Tongue cancer metastatic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsil cancer
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell cancer of the renal pelvis and ureter
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Transitional cell carcinoma recurrent
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour ulceration
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral cancer
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine cancer
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine leiomyoma
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Accelerated hypertension
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angiodysplasia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic aneurysm
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Aortic stenosis
subjects affected / exposed	4 / 4089 (0.10%)	10 / 4090 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriovenous fistula
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure fluctuation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	5 / 4089 (0.12%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Embolism arterial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extravasation blood
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Extremity necrosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertension
subjects affected / exposed	12 / 4089 (0.29%)	16 / 4090 (0.39%)
occurrences causally related to treatment / all	0 / 12	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	15 / 4089 (0.37%)	11 / 4090 (0.27%)
occurrences causally related to treatment / all	0 / 15	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive emergency
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotension
subjects affected / exposed	9 / 4089 (0.22%)	11 / 4090 (0.27%)
occurrences causally related to treatment / all	0 / 9	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Iliac artery occlusion
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	1 / 4089 (0.02%)	1 / 4090 (0.02%)
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	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leriche syndrome
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant hypertension
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Orthostatic hypotension
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral artery occlusion
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Peripheral embolism
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral vascular disorder
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renovascular hypertension
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shock
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Shock haemorrhagic
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Temporal arteritis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombophlebitis superficial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vena cava thrombosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Aortic valve replacement
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Artificial urinary sphincter implant
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ablation
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Endotracheal intubation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric bypass
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip arthroplasty
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hospitalisation
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Implantable defibrillator insertion
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Knee arthroplasty
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal polypectomy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung lobectomy
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polypectomy
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff repair
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Shoulder operation
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal operation
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stem cell transplant
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transurethral bladder resection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transurethral prostatectomy
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Adverse drug reaction
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthenia
subjects affected / exposed	6 / 4089 (0.15%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	1 / 4089 (0.02%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Chest pain
subjects affected / exposed	66 / 4089 (1.61%)	66 / 4090 (1.61%)
occurrences causally related to treatment / all	0 / 75	0 / 68
deaths causally related to treatment / all	0 / 0	0 / 0
Chills
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Complication associated with device
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cyst
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Drowning
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Exercise tolerance decreased
subjects affected / exposed	0 / 4089 (0.00%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Fatigue
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Generalised oedema
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated hernia
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Malaise
subjects affected / exposed	5 / 4089 (0.12%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Non-cardiac chest pain
subjects affected / exposed	49 / 4089 (1.20%)	52 / 4090 (1.27%)
occurrences causally related to treatment / all	1 / 52	0 / 58
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic mass
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral swelling
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polyp
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Suprapubic pain
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Swelling
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	1 / 4089 (0.02%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 1	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 2
Ulcer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ulcer haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular stent restenosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Allergy to arthropod sting
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic reaction
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anaphylactic shock
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Hypersensitivity
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sarcoidosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Adnexa uteri mass
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Benign prostatic hyperplasia
subjects affected / exposed	18 / 4089 (0.44%)	11 / 4090 (0.27%)
occurrences causally related to treatment / all	0 / 18	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endometrial hypoplasia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Menorrhagia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian cyst ruptured
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic prolapse
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peyronie's disease
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatism
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	6 / 4089 (0.15%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatomegaly
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Seminal vesicular cyst
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Testicular cyst
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Uterine prolapse
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vaginal prolapse
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	19 / 4089 (0.46%)	18 / 4090 (0.44%)
occurrences causally related to treatment / all	1 / 21	0 / 20
deaths causally related to treatment / all	0 / 2	0 / 4
Aspiration
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Asthma
subjects affected / exposed	9 / 4089 (0.22%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial fistula
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial hyperreactivity
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 4089 (0.00%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis chronic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchospasm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	33 / 4089 (0.81%)	34 / 4090 (0.83%)
occurrences causally related to treatment / all	0 / 44	0 / 74
deaths causally related to treatment / all	0 / 1	0 / 2
Dyspnoea
subjects affected / exposed	16 / 4089 (0.39%)	13 / 4090 (0.32%)
occurrences causally related to treatment / all	0 / 18	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	4 / 4089 (0.10%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	7 / 4089 (0.17%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	1 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Haemoptysis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hiccups
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercapnia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
subjects affected / exposed	3 / 4089 (0.07%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal polyps
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal septum deviation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal turbinate hypertrophy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal mass
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	7 / 4089 (0.17%)	11 / 4090 (0.27%)
occurrences causally related to treatment / all	0 / 7	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	1 / 4089 (0.02%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumomediastinum
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	7 / 4089 (0.17%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonitis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	14 / 4089 (0.34%)	22 / 4090 (0.54%)
occurrences causally related to treatment / all	0 / 16	0 / 22
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary fibrosis
subjects affected / exposed	4 / 4089 (0.10%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	2 / 5	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary hypertension
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	3 / 4089 (0.07%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 3	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory acidosis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	16 / 4089 (0.39%)	15 / 4090 (0.37%)
occurrences causally related to treatment / all	0 / 17	0 / 17
deaths causally related to treatment / all	0 / 4	0 / 3
Rhinitis allergic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sleep apnoea syndrome
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Status asthmaticus
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheal mass
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Wheezing
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Acute psychosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aggression
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Agitated depression
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Anxiety
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bipolar disorder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 2
Confusional state
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium
subjects affected / exposed	5 / 4089 (0.12%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Delirium tremens
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Depression
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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 / 4089 (0.00%)	1 / 4090 (0.02%)
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	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Panic attack
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Schizoaffective disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device breakage
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device failure
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device malfunction
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Device occlusion
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Alcoholic liver disease
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary colic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary dilatation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	4 / 4089 (0.10%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	9 / 4089 (0.22%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	15 / 4089 (0.37%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 15	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	15 / 4089 (0.37%)	18 / 4090 (0.44%)
occurrences causally related to treatment / all	0 / 15	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Cholestasis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cryptogenic cirrhosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder disorder
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder enlargement
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gallbladder polyp
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Hepatic steatosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic hepatitis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Jaundice cholestatic
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Non-alcoholic steatohepatitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Anticoagulation drug level above therapeutic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriogram coronary
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biopsy pleura
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood glucose increased
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure difference of extremities
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood pressure increased
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac murmur
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction abnormal
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ejection fraction decreased
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram T wave abnormal
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza A virus test positive
subjects affected / exposed	0 / 4089 (0.00%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza virus test positive
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lipase increased
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostatic specific antigen increased
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Anaemia postoperative
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Avulsion fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Axillary nerve injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone fragmentation
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain contusion
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon monoxide poisoning
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cartilage injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chest injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Clavicle fracture
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Compression fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Craniocerebral injury
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Dislocation of sternum
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	16 / 4089 (0.39%)	15 / 4090 (0.37%)
occurrences causally related to treatment / all	0 / 17	0 / 17
deaths causally related to treatment / all	0 / 1	0 / 0
Femoral neck fracture
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Femur fracture
subjects affected / exposed	4 / 4089 (0.10%)	10 / 4090 (0.24%)
occurrences causally related to treatment / all	0 / 5	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Fibula fracture
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foot fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Forearm fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Foreign body in gastrointestinal tract
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fractured sacrum
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	5 / 4089 (0.12%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Heat stroke
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	8 / 4089 (0.20%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 10	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	3 / 4089 (0.07%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Incarcerated incisional hernia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	6 / 4089 (0.15%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 6	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Jaw fracture
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Joint dislocation
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Laceration
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ligament injury
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	4 / 4089 (0.10%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Meniscus injury
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple fractures
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle strain
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Overdose
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Patella fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Periprosthetic fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Poisoning deliberate
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post laminectomy syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural discharge
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematoma
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	5 / 4089 (0.12%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	1 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural pulmonary embolism
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural swelling
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative adhesion
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative fever
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative hernia
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative ileus
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative renal failure
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative thrombosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural hypertension
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Procedural pain
subjects affected / exposed	0 / 4089 (0.00%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pubis fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radiation oesophagitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	5 / 4089 (0.12%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	3 / 4089 (0.07%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Sciatic nerve injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skull fractured base
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal compression fracture
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal fracture
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stomal hernia
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stress fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	9 / 4089 (0.22%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haemorrhage
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	4 / 4089 (0.10%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thoracic vertebral fracture
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tibia fracture
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic haematoma
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic intracranial haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Traumatic liver injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Traumatic renal injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric anastomosis complication
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral injury
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound dehiscence
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreas divisum
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	6 / 4089 (0.15%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	1 / 4089 (0.02%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Angina pectoris
subjects affected / exposed	48 / 4089 (1.17%)	48 / 4090 (1.17%)
occurrences causally related to treatment / all	0 / 53	0 / 50
deaths causally related to treatment / all	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	41 / 4089 (1.00%)	53 / 4090 (1.30%)
occurrences causally related to treatment / all	0 / 43	0 / 55
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve disease mixed
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve incompetence
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Aortic valve stenosis
subjects affected / exposed	10 / 4089 (0.24%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 10	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Arrhythmia
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arteriosclerosis coronary artery
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Arteriospasm coronary
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	21 / 4089 (0.51%)	17 / 4090 (0.42%)
occurrences causally related to treatment / all	0 / 22	0 / 18
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block complete
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrioventricular block second degree
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bradycardia
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bundle branch block left
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	4 / 4089 (0.10%)	9 / 4090 (0.22%)
occurrences causally related to treatment / all	0 / 4	0 / 9
deaths causally related to treatment / all	0 / 1	0 / 4
Cardiac failure
subjects affected / exposed	7 / 4089 (0.17%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 7	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Cardiac failure chronic
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiac failure congestive
subjects affected / exposed	19 / 4089 (0.46%)	13 / 4090 (0.32%)
occurrences causally related to treatment / all	0 / 19	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac tamponade
subjects affected / exposed	0 / 4089 (0.00%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac valve disease
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac ventricular thrombosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	0 / 4089 (0.00%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 2
Cardiogenic shock
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	4 / 4089 (0.10%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	1 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Congestive cardiomyopathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cor pulmonale chronic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	9 / 4089 (0.22%)	16 / 4090 (0.39%)
occurrences causally related to treatment / all	0 / 9	0 / 17
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery dissection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery occlusion
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive heart disease
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular dysfunction
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Left ventricular failure
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microvascular coronary artery disease
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	4 / 4089 (0.10%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	4 / 4089 (0.10%)	12 / 4090 (0.29%)
occurrences causally related to treatment / all	0 / 4	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 5
Myocardial ischaemia
subjects affected / exposed	4 / 4089 (0.10%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Palpitations
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	1 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Pleuropericarditis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Silent myocardial infarction
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus node dysfunction
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stress cardiomyopathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Supraventricular extrasystoles
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia paroxysmal
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular arrhythmia
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular parasystole
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular tachycardia
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Acute disseminated encephalomyelitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Altered state of consciousness
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Amyotrophic lateral sclerosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Aphasia
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ataxia
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Autonomic nervous system imbalance
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery disease
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Carotid artery occlusion
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carpal tunnel syndrome
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrospinal fluid leakage
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	3 / 4089 (0.07%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 0
Cervical radiculopathy
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cognitive disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dementia Alzheimer's type
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Demyelinating polyneuropathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic neuropathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dizziness
subjects affected / exposed	11 / 4089 (0.27%)	10 / 4090 (0.24%)
occurrences causally related to treatment / all	0 / 12	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Dural arteriovenous fistula
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	7 / 4089 (0.17%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 7	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic transformation stroke
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Headache
subjects affected / exposed	3 / 4089 (0.07%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 3	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hemiparesis
subjects affected / exposed	0 / 4089 (0.00%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Hydrocephalus
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive encephalopathy
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoaesthesia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic coma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Hypoglycaemic encephalopathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemic unconsciousness
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
IIIrd nerve paralysis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intracranial mass
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar radiculopathy
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis relapse
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Myelopathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuralgia
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Neurodegenerative disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Neurological symptom
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Paraesthesia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Polyneuropathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Presyncope
subjects affected / exposed	6 / 4089 (0.15%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 6	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudoradicular syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Quadriplegia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Radicular syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reversible ischaemic neurological deficit
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	3 / 4089 (0.07%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Sensory ganglionitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Speech disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal cord herniation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Status epilepticus
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	28 / 4089 (0.68%)	31 / 4090 (0.76%)
occurrences causally related to treatment / all	1 / 31	0 / 36
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic encephalopathy
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient global amnesia
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	8 / 4089 (0.20%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 8	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal nerve disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Trigeminal neuralgia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Unresponsive to stimuli
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular dementia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Vasogenic cerebral oedema
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vocal cord paralysis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	22 / 4089 (0.54%)	20 / 4090 (0.49%)
occurrences causally related to treatment / all	0 / 22	0 / 24
deaths causally related to treatment / all	0 / 0	0 / 0
Autoimmune haemolytic anaemia
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhagic anaemia
subjects affected / exposed	4 / 4089 (0.10%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Immune thrombocytopenic purpura
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency anaemia
subjects affected / exposed	4 / 4089 (0.10%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoid tissue hyperplasia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Normocytic anaemia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pernicious anaemia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic infarction
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Splenomegaly
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Thrombotic microangiopathy
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Inner ear disorder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sudden hearing loss
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo
subjects affected / exposed	5 / 4089 (0.12%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 5	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Vertigo positional
subjects affected / exposed	2 / 4089 (0.05%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Vestibular disorder
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Chalazion
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye swelling
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eyelid ptosis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal artery occlusion
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal detachment
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retinal vein thrombosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Visual impairment
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal adhesions
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia
subjects affected / exposed	3 / 4089 (0.07%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal hernia obstructive
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	7 / 4089 (0.17%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 8	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	5 / 4089 (0.12%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendix disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic gastritis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	6 / 4089 (0.15%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 7	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ischaemic
subjects affected / exposed	5 / 4089 (0.12%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	6 / 4089 (0.15%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	5 / 4089 (0.12%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 5	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulum intestinal haemorrhagic
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 4	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal perforation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Duodenal ulcer
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer haemorrhage
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenitis haemorrhagic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenogastric reflux
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Enteritis
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterovesical fistula
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epigastric discomfort
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Faeces discoloured
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric antral vascular ectasia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric perforation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric polyps
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	5 / 4089 (0.12%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer haemorrhage
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer perforation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Gastritis
subjects affected / exposed	0 / 4089 (0.00%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis erosive
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroduodenitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal angiodysplasia haemorrhagic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	26 / 4089 (0.64%)	20 / 4090 (0.49%)
occurrences causally related to treatment / all	1 / 28	1 / 20
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal pain
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	4 / 4089 (0.10%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haematemesis
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoidal haemorrhage
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhoids
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	2 / 4089 (0.05%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	11 / 4089 (0.27%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 11	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal ischaemia
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 1	0 / 0
Intestinal obstruction
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intra-abdominal haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Irritable bowel syndrome
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestinal haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Large intestine polyp
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 4	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	5 / 4089 (0.12%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 6	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mallory-Weiss syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	3 / 4089 (0.07%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Mesenteric arterial occlusion
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Mouth haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	4 / 4089 (0.10%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstructive pancreatitis
subjects affected / exposed	2 / 4089 (0.05%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal food impaction
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophageal pain
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatic mass
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	3 / 4089 (0.07%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 3	1 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	4 / 4089 (0.10%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	1 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis haemorrhagic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Peptic ulcer
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peptic ulcer haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal adhesions
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritoneal disorder
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngo-oesophageal diverticulum
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Portal hypertensive gastropathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Proctitis ulcerative
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	10 / 4089 (0.24%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 11	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal polyp
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal prolapse
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal fibrosis
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	16 / 4089 (0.39%)	12 / 4090 (0.29%)
occurrences causally related to treatment / all	0 / 19	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Strangulated umbilical hernia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subileus
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis mesenteric vessel
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Umbilical hernia
subjects affected / exposed	1 / 4089 (0.02%)	10 / 4090 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Volvulus
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	7 / 4089 (0.17%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dermal cyst
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ulcer
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ecchymosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Granuloma annulare
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperhidrosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Panniculitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Photosensitivity reaction
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash erythematous
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin ulcer
subjects affected / exposed	5 / 4089 (0.12%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Urticaria
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	47 / 4089 (1.15%)	34 / 4090 (0.83%)
occurrences causally related to treatment / all	1 / 52	0 / 41
deaths causally related to treatment / all	0 / 2	0 / 0
Acute prerenal failure
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder dysfunction
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder neck obstruction
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder outlet obstruction
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder prolapse
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder stenosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus bladder
subjects affected / exposed	0 / 4089 (0.00%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	6 / 4089 (0.15%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis haemorrhagic
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic nephropathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dysuria
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	8 / 4089 (0.20%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertonic bladder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Incontinence
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	13 / 4089 (0.32%)	12 / 4090 (0.29%)
occurrences causally related to treatment / all	0 / 14	0 / 15
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nephropathy toxic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal artery fibromuscular dysplasia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal colic
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Renal cyst
subjects affected / exposed	4 / 4089 (0.10%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal disorder
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	11 / 4089 (0.27%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 1
Renal haemorrhage
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	5 / 4089 (0.12%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stag horn calculus
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Stress urinary incontinence
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric dilatation
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureteric stenosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	6 / 4089 (0.15%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 6	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral meatus stenosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary bladder polyp
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary incontinence
subjects affected / exposed	0 / 4089 (0.00%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	5 / 4089 (0.12%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocrine disorders
Addison's disease
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Goitre
subjects affected / exposed	0 / 4089 (0.00%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthyroidism
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypothyroidism
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Inappropriate antidiuretic hormone secretion
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Thyroid mass
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Toxic nodular goitre
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	7 / 4089 (0.17%)	9 / 4090 (0.22%)
occurrences causally related to treatment / all	0 / 8	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis
subjects affected / exposed	6 / 4089 (0.15%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 6	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Arthropathy
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back disorder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	17 / 4089 (0.42%)	11 / 4090 (0.27%)
occurrences causally related to treatment / all	0 / 18	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cervical spinal stenosis
subjects affected / exposed	1 / 4089 (0.02%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Coccydynia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Costochondritis
subjects affected / exposed	0 / 4089 (0.00%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Exostosis
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Flank pain
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Foot deformity
subjects affected / exposed	2 / 4089 (0.05%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty arthritis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gouty tophus
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haemarthrosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc compression
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc degeneration
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	16 / 4089 (0.39%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 16	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Joint range of motion decreased
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Knee deformity
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	10 / 4089 (0.24%)	10 / 4090 (0.24%)
occurrences causally related to treatment / all	0 / 10	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Mandibular mass
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mobility decreased
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle spasms
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Muscular weakness
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	6 / 4089 (0.15%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	5 / 4089 (0.12%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Myalgia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Neck pain
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	81 / 4089 (1.98%)	73 / 4090 (1.78%)
occurrences causally related to treatment / all	0 / 89	0 / 81
deaths causally related to treatment / all	0 / 0	0 / 0
Osteochondrosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in extremity
subjects affected / exposed	5 / 4089 (0.12%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pain in jaw
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Polymyalgia rheumatica
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudarthrosis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatic fever
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	0 / 4089 (0.00%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	10 / 4089 (0.24%)	12 / 4090 (0.29%)
occurrences causally related to treatment / all	0 / 11	0 / 13
deaths causally related to treatment / all	0 / 0	0 / 0
Soft tissue mass
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal column stenosis
subjects affected / exposed	11 / 4089 (0.27%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 12	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sympathetic posterior cervical syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Synovial cyst
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Temporomandibular joint syndrome
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tendonitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal infection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal wall abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess intestinal
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Acquired immunodeficiency syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	2 / 4089 (0.05%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	9 / 4089 (0.22%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 9	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis perforated
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	4 / 4089 (0.10%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	3 / 4089 (0.07%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 3	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial sepsis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Biliary abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	11 / 4089 (0.27%)	10 / 4090 (0.24%)
occurrences causally related to treatment / all	0 / 11	0 / 10
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis bacterial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis viral
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bursitis infective
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Campylobacter gastroenteritis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Catheter site cellulitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	36 / 4089 (0.88%)	28 / 4090 (0.68%)
occurrences causally related to treatment / all	0 / 38	0 / 39
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis streptococcal
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis infective
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis bacterial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cystitis escherichia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dengue fever
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Device related sepsis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	11 / 4089 (0.27%)	9 / 4090 (0.22%)
occurrences causally related to treatment / all	0 / 11	0 / 9
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis intestinal haemorrhagic
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	1 / 4089 (0.02%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal bacteraemia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epiglottitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (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	13 / 4089 (0.32%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 16	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gas gangrene
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	16 / 4089 (0.39%)	16 / 4090 (0.39%)
occurrences causally related to treatment / all	0 / 16	0 / 16
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	5 / 4089 (0.12%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal bacterial overgrowth
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Genital infection fungal
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Graft infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Groin abscess
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
H1N1 influenza
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Helicobacter gastritis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis viral
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
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	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Implant site infection
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Incision site abscess
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Infectious colitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of bronchiectasis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infective exacerbation of chronic obstructive airways disease
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Influenza
subjects affected / exposed	2 / 4089 (0.05%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 1
Intervertebral discitis
subjects affected / exposed	3 / 4089 (0.07%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Joint abscess
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Keratitis bacterial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella infection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	3 / 4089 (0.07%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Latent tuberculosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Listeriosis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Localised infection
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 3	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 4089 (0.02%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Lower respiratory tract infection viral
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mastitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Meningitis bacterial
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mycobacterial infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Necrotising fasciitis
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic sepsis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Orchitis
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	12 / 4089 (0.29%)	7 / 4090 (0.17%)
occurrences causally related to treatment / all	0 / 14	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Osteomyelitis acute
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Otitis media acute
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parainfluenzae virus infection
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Parasitic gastroenteritis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pelvic abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngolaryngeal abscess
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pilonidal cyst
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumococcal sepsis
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	105 / 4089 (2.57%)	118 / 4090 (2.89%)
occurrences causally related to treatment / all	0 / 128	0 / 137
deaths causally related to treatment / all	0 / 9	0 / 4
Pneumonia bacterial
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pseudomonal
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	1 / 4089 (0.02%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia streptococcal
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural cellulitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative abscess
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Postoperative wound infection
subjects affected / exposed	8 / 4089 (0.20%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 9	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pseudomembranous colitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Pseudomonas infection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelocystitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	7 / 4089 (0.17%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 7	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	2 / 4089 (0.05%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection viral
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rhinovirus infection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rotavirus infection
subjects affected / exposed	0 / 4089 (0.00%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	25 / 4089 (0.61%)	31 / 4090 (0.76%)
occurrences causally related to treatment / all	0 / 29	0 / 34
deaths causally related to treatment / all	0 / 2	0 / 4
Sepsis syndrome
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	12 / 4089 (0.29%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 13	0 / 3
deaths causally related to treatment / all	0 / 4	0 / 2
Shunt infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sialoadenitis
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	3 / 4089 (0.07%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal infection
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Streptococcal sepsis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subacute endocarditis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Systemic candida
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tick-borne fever
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tooth abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	1 / 4089 (0.02%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1
Urinary tract infection
subjects affected / exposed	25 / 4089 (0.61%)	22 / 4090 (0.54%)
occurrences causally related to treatment / all	0 / 32	0 / 23
deaths causally related to treatment / all	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	11 / 4089 (0.27%)	9 / 4090 (0.22%)
occurrences causally related to treatment / all	0 / 13	0 / 11
deaths causally related to treatment / all	0 / 1	0 / 2
Viral infection
subjects affected / exposed	1 / 4089 (0.02%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Viral sepsis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vulval cellulitis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound abscess
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	4 / 4089 (0.10%)	2 / 4090 (0.05%)
occurrences causally related to treatment / all	0 / 4	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection staphylococcal
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wound sepsis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dehydration
subjects affected / exposed	16 / 4089 (0.39%)	11 / 4090 (0.27%)
occurrences causally related to treatment / all	0 / 16	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	11 / 4089 (0.27%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	5 / 4089 (0.12%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic ketoacidosis
subjects affected / exposed	4 / 4089 (0.10%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diabetic metabolic decompensation
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Failure to thrive
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	2 / 4089 (0.05%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypercalcaemia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	10 / 4089 (0.24%)	8 / 4090 (0.20%)
occurrences causally related to treatment / all	0 / 12	0 / 8
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemic hyperosmolar nonketotic syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperkalaemia
subjects affected / exposed	3 / 4089 (0.07%)	6 / 4090 (0.15%)
occurrences causally related to treatment / all	0 / 4	0 / 7
deaths causally related to treatment / all	0 / 0	0 / 0
Hypernatraemia
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperosmolar state
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	15 / 4089 (0.37%)	14 / 4090 (0.34%)
occurrences causally related to treatment / all	0 / 15	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	3 / 4089 (0.07%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	1 / 5	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	5 / 4089 (0.12%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	1 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Hypophosphataemia
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemia
subjects affected / exposed	2 / 4089 (0.05%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Iron deficiency
subjects affected / exposed	0 / 4089 (0.00%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	1 / 4089 (0.02%)	1 / 4090 (0.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic acidosis
subjects affected / exposed	2 / 4089 (0.05%)	3 / 4090 (0.07%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Obesity
subjects affected / exposed	9 / 4089 (0.22%)	5 / 4090 (0.12%)
occurrences causally related to treatment / all	0 / 9	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
Shock hypoglycaemic
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tumour lysis syndrome
subjects affected / exposed	1 / 4089 (0.02%)	0 / 4090 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Type 2 diabetes mellitus
subjects affected / exposed	2 / 4089 (0.05%)	4 / 4090 (0.10%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	AMR101	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	3268 / 4089 (79.92%)	3248 / 4090 (79.41%)
Vascular disorders
Hypertension
subjects affected / exposed	312 / 4089 (7.63%)	333 / 4090 (8.14%)
occurrences all number	340	375
Nervous system disorders
Dizziness
subjects affected / exposed	227 / 4089 (5.55%)	238 / 4090 (5.82%)
occurrences all number	264	278
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	178 / 4089 (4.35%)	224 / 4090 (5.48%)
occurrences all number	201	244
General disorders and administration site conditions
Chest pain
subjects affected / exposed	226 / 4089 (5.53%)	240 / 4090 (5.87%)
occurrences all number	265	305
Fatigue
subjects affected / exposed	227 / 4089 (5.55%)	195 / 4090 (4.77%)
occurrences all number	239	206
Oedema peripheral
subjects affected / exposed	264 / 4089 (6.46%)	201 / 4090 (4.91%)
occurrences all number	296	242
Eye disorders
Cataract
subjects affected / exposed	230 / 4089 (5.62%)	205 / 4090 (5.01%)
occurrences all number	312	272
Gastrointestinal disorders
Constipation
subjects affected / exposed	216 / 4089 (5.28%)	142 / 4090 (3.47%)
occurrences all number	231	147
Diarrhoea
subjects affected / exposed	363 / 4089 (8.88%)	450 / 4090 (11.00%)
occurrences all number	452	565
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	241 / 4089 (5.89%)	241 / 4090 (5.89%)
occurrences all number	275	284
Dyspnoea
subjects affected / exposed	243 / 4089 (5.94%)	233 / 4090 (5.70%)
occurrences all number	280	282
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	309 / 4089 (7.56%)	306 / 4090 (7.48%)
occurrences all number	389	361
Back pain
subjects affected / exposed	322 / 4089 (7.87%)	303 / 4090 (7.41%)
occurrences all number	361	339
Pain in extremity
subjects affected / exposed	232 / 4089 (5.67%)	239 / 4090 (5.84%)
occurrences all number	285	282
Infections and infestations
Bronchitis
subjects affected / exposed	295 / 4089 (7.21%)	292 / 4090 (7.14%)
occurrences all number	361	377
Influenza
subjects affected / exposed	261 / 4089 (6.38%)	267 / 4090 (6.53%)
occurrences all number	314	331
Nasopharyngitis
subjects affected / exposed	314 / 4089 (7.68%)	300 / 4090 (7.33%)
occurrences all number	406	370
Upper respiratory tract infection
subjects affected / exposed	311 / 4089 (7.61%)	315 / 4090 (7.70%)
occurrences all number	417	416
Urinary tract infection
subjects affected / exposed	240 / 4089 (5.87%)	246 / 4090 (6.01%)
occurrences all number	356	361

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Were there any global substantial amendments to the protocol? Yes

16 May 2013

Fasting TG level at screening increased from 135 mg/dL (reflecting a 10% variability allowance from the target of 150 mg/dL) to 200 mg/dL (without a variability allowance).

08 Jul 2016

The composite of hard major adverse coronary event (MACE) endpoints (CV death, non-fatal MI, non-fatal stroke) was designated as the “key secondary endpoint” and secondary endpoints were streamlined and re-ordered to further elucidate primary and key secondary findings. Added an additional interim analysis to occur after approximately 80% of the total primary endpoint events are reached. Updated cardiovascular endpoint definitions per new version of Standardized Definitions for Endpoint Events in Cardiovascular Trials.

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

http://www.ncbi.nlm.nih.gov/pubmed/28294373
http://www.ncbi.nlm.nih.gov/pubmed/30898607
http://www.ncbi.nlm.nih.gov/pubmed/31707829
http://www.ncbi.nlm.nih.gov/pubmed/30415628
http://www.ncbi.nlm.nih.gov/pubmed/34620410
http://www.ncbi.nlm.nih.gov/pubmed/34706555
http://www.ncbi.nlm.nih.gov/pubmed/34710343
http://www.ncbi.nlm.nih.gov/pubmed/35027114
http://www.ncbi.nlm.nih.gov/pubmed/33010162
http://www.ncbi.nlm.nih.gov/pubmed/33148016
http://www.ncbi.nlm.nih.gov/pubmed/31439224

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, and Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization

Primary: Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, and Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization

Secondary: Composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke.

Secondary: Composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke.

Secondary: Composite of CV Death or Nonfatal MI (Including Silent MI).

Secondary: Composite of CV Death or Nonfatal MI (Including Silent MI).

Secondary: Fatal or Nonfatal MI (Including Silent MI).

Secondary: Fatal or Nonfatal MI (Including Silent MI).

Secondary: Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

Secondary: Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

Secondary: CV Death

Secondary: CV Death

Secondary: Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

Secondary: Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

Secondary: Fatal or Nonfatal Stroke.

Secondary: Fatal or Nonfatal Stroke.

Secondary: Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

Secondary: Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

Secondary: Total Mortality.

Secondary: Total Mortality.

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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